Online Events on Pharma (past events)

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Drafting Commercial Contracts for the Pharmaceutical Industry
Nov 2024
Hippo Pathway Targeted Drug Development Summit
Nov 2024
Antibody Engineering with Novel Technologies Online Symposium
Nov 2024
Signal Detection and Regulatory Expectations
Nov 2024
The International Electronic Conference on Clinical Medicine (ECCM)
Nov 2024
Stability Testing of Pharmaceuticals and Biopharmaceuticals
Nov 2024
Audits - Self/Internal, Vendor and Regulatory Inspections
Nov 2024
Drafting and Negotiating Clinical Trial Agreements
Nov 2024
Advanced Screening Approaches in Drug Delivery
Oct 2024
Indegene Digital Summit Virtual
Oct 2024
Leachables and Extractables MasterClass - EU
Oct 2024
International Conference on Advances in Biological Science and Technology (ICABST)
Sep 2024
Process Validation for Biotechnological Products - US
Sep 2024
Post-Authorisation Safety Studies MasterClass- EU
Sep 2024
Drug Product registration process in the US MasterClass
Sep 2024
Global Meet on Toxicology (GMTOXI)
Sep 2024
Cell Bank Establishment & Testing MasterClass - EU
Sep 2024
Pharma Contract Drafting MasterClass - EU
Aug 2024
Pharma Contract Drafting MasterClass - US
Aug 2024
International Virtual Conference on Chemistry & Pharmaceutical Chemistry
Aug 2024
Key Aspects of Analytical Development MasterClass - US
Jul 2024
EU and UK procedures for marketing authorisation Masterclass - US
Jun 2024
Global Meet on Pharmaceutics and Drug Delivery Systems (GMPDDS)
May 2024
Safety Data Exchange Agreements (SDEA) in Pharmacovigilance: Training Course + Workshop
May 2024
Global Summit on Bioavailability and Bioequivalence
May 2024
International Conference on Biomedicine (ICBM
May 2024
Advanced Protein Aggregation & Characterization
Apr 2024
International Conference on Life Sciences (LiSci)
Apr 2024
International conference on Bioinformatics and computational studies (ICBCS)
Apr 2024
The International Electronic Conference on Toxics
Mar 2024
Implementation of Single-Use Technology in Biopharmaceutical Production
Mar 2024
Toxicology, ADME & Early Drug Development Plan
Mar 2024
Annual Extractables and Leachables Summit
Mar 2024
Signal Management In Pharmacovigilance
Feb 2024
Fundamentals of Good Manufacturing Practices for Biopharmaceuticals
Feb 2024
International Conference on Vaccines & Infectious Diseases
Feb 2024
Chemical Development & Scale-up in The Fine Chemical & Pharmaceutical Industries
Jan 2024
International Conference on Clinical Pharmacy and Pharmaceutical Research (ICCPPR)
Dec 2023
Edition of International Conference on Microbiology, Antibiotics and Public Health
Dec 2023
Global Summit on Chemistry & Pharmaceutical Chemistry
Dec 2023
The International Electronic Conference on Antibiotics (ECA)
Dec 2023
GCP Inspection Readiness
Dec 2023
Advanced Nano Drug Delivery Systems
Nov 2023
Implementation of a Successful Technology Transfer Process
Nov 2023
Safety Data Exchange Agreements (SDEAs) and PV Arrangements with External Vendors MasterClass
Nov 2023
Advanced Stability Testing of Pharmaceuticals MasterClass
Oct 2023
International Conference on Central Nervous System and Therapeutics
Oct 2023
Sana Symposium - Psychedelics Education for Mental Health & Addiction Professionals
Oct 2023
Global Summit on Vaccines Research & Development (GSVRD)
Oct 2023
Pediatric Early Development Symposium (PEDS)
Oct 2023
Evaluating Biopharma: Continuous Bioprocessing
Oct 2023
International Conference and Exhibition on Natural Products Chemistry and Medicinal Plants Research
Oct 2023
Antibodies, Next-Generation Proteins Therapeutics Summit
Sep 2023
Data Driven Approach in Clinical Trials
Sep 2023
Digital Pharma East
Sep 2023
Smart(er) Biomanufacturing: Evaluating the Risks and Opportunities
Sep 2023
International Conference on Vaccines: Research and Development
Jul 2023
Purification: New Technologies and Strategies to Support Complex Molecules
Jun 2023
Clinical Trials Quality & Inspection Updates
May 2023
IOTOD : Improving outcomes in the treatment of opioid dependence
May 2023
Good Laboratory Practice & Good Clinical Laboratory Practice
May 2023
Stability & Shelf Life of Biologics
May 2023
Comparability for Biologics
Apr 2023
Bioassays & Bioanalytical Methods
Apr 2023
Antibody Engineering & Therapeutics ASIA
Apr 2023
eCTD Submissions
Apr 2023
The International Respati Health Conference (IRHC)
Mar 2023
BA/BE & Biowaivers
Mar 2023
International Conference on Global issues in Multidisciplinary Academic Research
Mar 2023
KOL Engagement Virtual Summit
Mar 2023
New ICH & EMA Quality Guidelines
Feb 2023
Evaluating Biopharma - Cell Culture Optimization
Feb 2023
Bacteriophage Therapy Summit
Feb 2023
Clinical Data Disclosure and Transparency Summit
Feb 2023
Life Sciences, Clinical Trials, Patient Recruitment & Retention
Jan 2023
Evaluating Biopharma - Gene Therapy Analytics
Jan 2023
International Conference on Pharmaceutics and Pharmacology Research
Jan 2023
Strategy for Cell & Gene Therapies
Jan 2023
Life Sciences, Commercialization & HEOR - 4 Key Trends for Commercial Success in
Jan 2023
Lipid-Based Drug Delivery: Dosage Form Design from Preclinical to -in-Human
Jan 2023
Evaluating Biopharma - Cell Therapy Strategies
Dec 2022
Project Management for Pharma Professionals
Dec 2022
TIGIT Therapies Digital Summit
Dec 2022
FAAM-EUROBAT Digital
Dec 2022
International Conference on Drug Discovery and Drug Development
Nov 2022
Pharma M&A MasterClass
Nov 2022
Emerging Non-Coding RNA Therapeutics Summit
Nov 2022
ISMA-RHINA Digital
Nov 2022
International Conference on Pharmacology and Toxicology
Nov 2022
Pharmacovigilance Audit and Inspections EU MasterClass
Oct 2022
Cleaning Validation Principles MasterClass - EU
Oct 2022
Quality control for ATMPs and Biologics MasterClass
Oct 2022
Global Summit On Medicinal Plants And Natural Products
Oct 2022
Pharmaceutical Packaging, Labelling and Artwork Origination
Oct 2022
Pharma Packaging MasterClass
Oct 2022
Implementation of ISO 13485 MasterClass
Oct 2022
Evaluating Biopharma - Supply Chain Challenges
Oct 2022
Vaccine Development MasterClass
Oct 2022
Viral Clearance MasterClass
Oct 2022
Clinical Project Management MasterClass
Sep 2022
Leading a Strategic Account Management Approach in Pharma MasterClass
Sep 2022
International Conference on Nanomedicine and Drug delivery
Sep 2022
ISPOR Asia-Pacific Conference - International Society for Pharmacoeconomics and Outcomes Research
Sep 2022
Behavioural Good Manufacturing Practices MasterClass
Sep 2022
Patient Engagement in HTA Processes MasterClass
Sep 2022
Pharmacovigilance Audit and Inspections US MasterClass
Sep 2022
PK/PD in Drug Discovery and Development for the US market MasterClass
Sep 2022
CRO Oversight MasterClass
Sep 2022
Advanced Stability Testing of Pharmaceuticals Asian MasterClass
Sep 2022
Cannabis for the Biotechnology, Pharmaceutical and Nutraceutical Industry MasterClass
Sep 2022
Pediatric Drug Development MasterClass
Sep 2022
Pharmacovigilance System Master File MasterClass
Sep 2022
Deviation and Change Control Management in Pharma MasterClass
Sep 2022
International Conference On Pharmacology And Toxicology
Aug 2022
World Congress on Pharmaceutical Research & Drug Discovery
Jul 2022
International Conference on Nutraceuticals
Jul 2022
Analytical Instrument Qualification & Validation - Use of Excel and FDA Audit Preparation
Jul 2022
European Conference on Rare Diseases and Orphan Products (ECRD)
Jul 2022
World Congress on Pharmaceutical Biotechnology
Jun 2022
Rare and Genetic Neurodegenerative Drug Development Summit
Jun 2022
How to Apply for a Breakthrough Therapy Designation and Win It
Jun 2022
International Conference on Pharmaceutics and Novel Drug Delivery Systems
Jun 2022
MENA Pharmacy Congress
Jun 2022
JAK Inhibitors Drug Development Summit
Jun 2022
Pre Event Respiratory Drugs
Jun 2022
Medical Writing & Communication Strategy
May 2022
Medical Device Regulations & Compliance Summit
May 2022
Due Diligence for Life Sciences Summit
May 2022
International Conference on Vaccines and Immunology
May 2022
Pharmaceutical and Medical Device Ethics and Compliance Congress
May 2022
Pharmaceutical Aseptic Processing Forum
May 2022
Pharma: Clinical
May 2022
Global Summit on Cancer And Oncology Research
May 2022
Understanding and Implementing a Quality by Design (QbD) Program
May 2022
U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs
May 2022
World Congress on Oncology and Cancer Research
May 2022
International Conference on Drug Discovery & Toxicology
May 2022
Pharmacokinetics (PK) / Pharmacodynamics (PD) Studies in Drug Discovery and Development
May 2022
Packaging and Labeling in Pharmaceutical Product Development - Best Practices
May 2022
Promotional Review Summit
May 2022
Global Summit on HIV-AIDS and STDs
Apr 2022
Clinical Trial Regulation MasterClass
Apr 2022
Immunogenicity MasterClass
Apr 2022
Nasal Drug Delivery
Apr 2022
International Conference and Exhibition on Nanomedicine and Pharmaceutical Nanotechnology
Apr 2022
EU Good Pharmacovigilance Practices MasterClass
Apr 2022
International Conference on Hematology and Bone Marrow Transplantation
Apr 2022
Global Pharmaceutical Regulatory Affairs Summit
Apr 2022
Advanced Quality Risk Management MasterClass
Apr 2022
Extractables & Leachables for Pharma Summit
Mar 2022
Scholars International Webinar on Advances in Drug Discovery and Development
Mar 2022
International Conference on Clinical Research and Clinical Trials
Mar 2022
3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process
Mar 2022
Agile Leadership for Pharma and Biopharma Professionals in a virtual world
Mar 2022
Pharma Crisis Communication MasterClass
Mar 2022
Cardiometabolic Health & Diabetes Africa Congress
Feb 2022
Pharma Analysing and Drafting Commercial
Feb 2022
Genetic Vaccine Analytical Development Summit
Feb 2022
Asian Conference on Clinical Pharmacy (ACCP)
Feb 2022
MEDICHEM Congress
Feb 2022
3D Cell Culture
Feb 2022
International Conference on Traditional Medicine, Phytochemistry and Medicinal Plants (TMedPM)
Feb 2022
Advanced CMC MasterClass
Feb 2022
Regulated LC-MS Bioanalysis Masterclass
Jan 2022
HFpEF Drug Discovery and Development Summit | Digital Event
Jan 2022
Speaker Programs and Advisory Boards
Jan 2022
Multi-Functional Cell Therapies Summit
Jan 2022
LAG-3 Targeted Drug Development Summit
Jan 2022
Pharmaceutical Microbiology
Jan 2022
International Conference on Toxicogenomics
Dec 2021
Cleaning Validation for Pharma
Dec 2021
FDA Pharmaceutical Labeling Boot Camp
Dec 2021
International Viral Hepatitis Elimination Meeting (IVHEM)
Dec 2021
Head and Neck Cancer Drug Development Summit
Dec 2021
Total Health Europe
Nov 2021
International Conference on Microbiology and Infectious diseases
Nov 2021
The EU Clinical Trial Regulation MasterClass
Nov 2021
CMC Readiness Challenge in case of Expedited Programs for Biotechnological Products MasterClass
Nov 2021
Signal and Risk Management in Pharmacovigilance MasterClass
Nov 2021
International Virtual Conference on Clinical Trials and Case Reports
Nov 2021
Pharma & Healthcare Comms & Reputation Conference
Nov 2021
World Congress on Vaccines and Immunization
Nov 2021
Biotherapeutics US
Nov 2021
Wnt & B-Catenin Targeted Drug Discovery Summit
Nov 2021
RSV Drug Development Summit
Nov 2021
Regulatory and Technology Considerations for the Design of Medical Device Software MasterClass
Nov 2021
The OECD Principles of Good Laboratory Practices (GLP) MasterClass
Nov 2021
US Safety Data Exchange Agreements (SDEAs) and PV Arrangements with External Vendors MasterClass
Nov 2021
Biomarker for Rare Diseases
Nov 2021
Early & Managed Access Programmes
Nov 2021
All you need to know to generated a valuable genetically engineered model
Nov 2021
Clinical Document World
Nov 2021
Vendor/CRO Management and Oversight MasterClass
Nov 2021
Pharma and Patient USA
Nov 2021
Gene Therapy for Rare Disorders Europe Summit
Nov 2021
Medical Device Digi Expo
Oct 2021
International Partnering Conference (BIO-Europe)
Oct 2021
Neoantigen Based Therapies Summit
Oct 2021
Pharmacy Career Conference (PharmaCC)
Oct 2021
Edition Injectables Summit
Oct 2021
Precision Data and Programmatic Marketing
Oct 2021
Webinar: Harnessing the Power of Bispecific Antibodies
Oct 2021
Combination Products Summit
Oct 2021
Temperature Control and Logistics US
Sep 2021
Unlocking the Potential of Cell & Gene Therapies MasterClass
Sep 2021
Critical Quality Attributes of Recombinant Proteins for Therapeutic Use MasterClass
Sep 2021
Building Digital Health Solutions MasterClass
Sep 2021
Blockchain for Pharmaceuticals MasterClass
Sep 2021
Global Pharma Awards
Sep 2021
Xcelerate at Biotech Week Boston
Sep 2021
Investigator Initiated Trials
Sep 2021
Pharmacovigilance on the Internet and Social Media MasterClass
Sep 2021
Gene Therapy for Metabolic Disorders
Sep 2021
National - Strategy Summit on Paragraph IV Litigation
Sep 2021
Chemical Industry Regulations
Sep 2021
Pharma Mergers and Acquisitions MasterClass
Sep 2021
A stakeholder engagement approach to Clinical Trials MasterClass
Sep 2021
Biomarkers for Alzheimer`s Disease Summit
Aug 2021
Neuropathic Pain Therapeutics Summit
Aug 2021
Prostate Cancer Drug Development Summit
Aug 2021
Integrin-Targeted Drug Discovery Summit
Aug 2021
Future Pharma
Aug 2021
International Conference on Advanced Pharmacy and Clinical Research
Aug 2021
National Institute for Health and Care Excellence (NICE), UK: Transformation in Action
Aug 2021
Congress on Nanomedicine and Drug Delivery
Aug 2021
Patient Recruitment, Engagement and Support Summit
Aug 2021
on Coronavirus and Research
Jul 2021
Congress on Clinical Microbiology and Yeast Congress
Jul 2021
Next Generation Food Allergy Drug Development
Jul 2021
International Conference on Technological Advancement in Science, Engineering, Management & Pharmaceutics (ICTASEMP)
Jul 2021
Non-Small Cell Lung Cancer Drug Development Summit
Jul 2021
Conference on Applied Pharmacology and Toxicology
Jul 2021
Pharma Customer Engagement Europe
Jul 2021
Digital Transformation Journey for Medical Affairs
Jun 2021
MENA Pharmaceutical Manufacturing Congress
Jun 2021
Biosimilars Congregation
Jun 2021
Psychedelic Opportunity Summit
Jun 2021
Global Bioprocessing: Pharma 4.0 Summit
Jun 2021
International Pharmacovigilance Days
Jun 2021
Pharma R&D Week
Jun 2021
Continuous Manufacturing Processes for Biotechnological Products MasterClass
Jun 2021
Decoding Digital Health for Life Sciences
Jun 2021
Biologics Formulation Development and Drug Delivery Forum
Jun 2021
Global Summit on Herbals & Traditional Medicine
Jun 2021
Pharma Supply Chain Conference
Jun 2021
Medicinal Cannabis Congress
Jun 2021
Pharma Pricing and Reimbursement Forum
May 2021
Benefit-Risk Assessment in Pharmacovigilance MasterClass
May 2021
Clinical Trial Supply Forum
May 2021
Best practices and tools for Pharma Project Management MasterClass
May 2021
Vaccines World Summit
May 2021
ProcureCon Pharma
May 2021
Strategic Resource & Portfolio Management
May 2021
International Conference on Cancer Research and Pharmacology
May 2021
Asia-Pacific Pharma Congress
May 2021
GxP in Pharma MasterClass
May 2021
Smart Packaging and Technical Operations in Pharma MasterClass
May 2021
Meet on Pharmaceutical Sciences
May 2021
SMi`s Pain Therapeutics Conference
May 2021
Development of Generics: From R&D to GMP MasterClass
May 2021
How to build the infrastructure to become a data-driven healthcare organization
May 2021
International Online Virology Congress
May 2021
Experimental Biology (EB)
Apr 2021
Strategic Alliance Management for Pharma
Apr 2021
NextGen Clinical Trial Innovation Summit
Apr 2021
Triple Negative Breast Cancer Drug Development Summit
Apr 2021
Virtual Symposium: Oligonucleotides: Chemistry & Therapeutic
Apr 2021
Biologics Europe Online
Apr 2021
Biosimilar Medicines Conference
Apr 2021
Anti-Infectives Drug Development Summit
Apr 2021
LogiPharma
Apr 2021
Clinical Trials V-Forum
Apr 2021
AI Driven Drug Repositioning and Repurposing
Apr 2021
Pharma & Biotech IP Connect
Apr 2021
International Conference on Pharmaceutics and Novel Drug Delivery System
Apr 2021
Personalized and Precision Medicine International Conference (PEMED)
Apr 2021
United Conference of Quality and Validation
Apr 2021
Latin America - Understanding Regulatory Compliance Requirements Across the Life Science Industry (Focus: Brazil, Mexico, Argentina)
Apr 2021
Advancing Prefabrication for Biopharma Facilities
Apr 2021
World Biosimilar Congress USA
Apr 2021
Medicinal & Pharmaceutical Sciences Congress
Apr 2021
Virtual On-line Conference on Clinical Trials & Clinical Research
Mar 2021
BIO-Europe Spring
Mar 2021
FcRn-Targeted Therapies for Autoimmune Disorders
Mar 2021
Pharma Contract Manufacturing Exchange
Mar 2021
Digital Pharma Europe
Mar 2021
NextGen Pharma Content
Mar 2021
Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices
Mar 2021
Sri Lanka Medical & Equipment Virtual Expo
Mar 2021
Oman International Paediatric Congress
Mar 2021
Supply Chain Re-Innovation: Life Sciences
Mar 2021
Pharma AI, IoT & Blockchain
Mar 2021
Drug Delivery Devices Symposium
Mar 2021
Medical Writing Landscape Advancement Summit
Mar 2021
Neurodegenerative Drug Development Summit
Feb 2021
International Conference on Clinical Trials
Feb 2021
The Ibogaine Conference: A Molecular Masterclass
Feb 2021
Molecular Med TRI-CON
Feb 2021
World Congress on Toxicology and Appleid Pharmacology
Feb 2021
World Congress on Toxicology and Applied Pharmacology
Feb 2021
Pharma Resource Planning & Portfolio Management
Feb 2021
International Conference on Clinical Chemistry and Laboratory Medicine
Feb 2021
Change Control Best Practices - Avoiding Unintended Consequences of Changes
Jan 2021
AI-ML Drug Discovery
Jan 2021
PARP & DDR Inhibitors Summit Digital
Jan 2021
Data Integrity: FDA/EU Requirements and Implementation
Jan 2021
Cannabinoid Derived Pharmaceuticals Summit Europe
Jan 2021
PepTalk: The Protein Science Week
Jan 2021
Pharmacovigilance
Dec 2020
International Conference on Medicinal Chemistry & Drug Discovery
Dec 2020
International Conference on Clinical Pharmacy and Clinical Research
Dec 2020
World Conference on Vaccine and Immunology
Dec 2020
Surfactant Research
Dec 2020
Clinically Validated Digital Therapeutics Summit
Dec 2020
Neuromuscular Drug Development Summit
Dec 2020
Endpoint Adjudication
Dec 2020
Oligonucleotides for Cardiovascular and Metabolic Disease Summit
Dec 2020
The International Society for Nutraceuticals and Functional Foods (ISNFF) Conference and Exhibition
Nov 2020
World Conference on Nano Drug Delivery
Nov 2020
Product Launch Excellence for Pharma & Biotech
Nov 2020
CAR-T Beyond Oncology Digital Event
Nov 2020
Combination Products Lifecycle Management (CPLM)
Nov 2020
Proteome - Targeted Drug Discovery Summit
Nov 2020
Pharma Virtual
Nov 2020
Biomarkers for Rare Non-Oncological Diseases Summit
Nov 2020
Product Complaints and Recalls Virtual Summit
Nov 2020
International Conference on Wound Care, Tissue Repair and Regenerative Medicine
Oct 2020
Clinical Innovation and Supply Chain Management
Oct 2020
Protein Misfolding Drug Discovery Summit
Oct 2020
Essentials Of USP Microbiology - For Those Who Are Not Microbiologists or Who Wish A Refresher
Oct 2020
Pharma Australia
Oct 2020
CannX Tel Aviv: The International Medical Cannabis Conference
Oct 2020
World Congress on Nutrition & Eating Disorders
Oct 2020
International Conference on Drug Design and Development
Oct 2020
World congress on Rare Diseases and Orphan Drugs
Oct 2020
International Conference on Medical Case Reports
Oct 2020
FDA`s Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering Training
Oct 2020
Psychedelic Drug Development Digital Summit
Oct 2020
International Conference and Expo on Pharmacognosy, Medicinal Plants and Natural Products
Oct 2020
The Drug Development Process from Concept to Market
Oct 2020
Med-Tech & Med-Cann World Summit
Oct 2020
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
Oct 2020
International Conference on Clinical Pharmacy
Oct 2020
International Conference on Pharmaceutical Regulatory Affairs and IPR
Oct 2020
D4 Global - Data-Driven Discovery and Development in Pharma R&D
Oct 2020
nanomedicine-pharma
Oct 2020
B-Cell Directed Therapies for Autoimmune Diseases
Oct 2020
International Healthcare Summit
Oct 2020
Neuropharmacology Congress
Oct 2020
Global Summit on Generic Drugs and Quality Control
Oct 2020
Global Forum for Qualified Person for Pharmacovigilance (QPPV)
Oct 2020
Project Management for FDA-Regulated Companies
Oct 2020
Digital Clinical Biomarkers and World CDx Summit
Oct 2020
International Conference on Pharmacoepidemiology and Clinical Research
Sep 2020
Risk Management in Clinical Research
Sep 2020
Virtual ISPOR-FDA Summit
Sep 2020
World ADC Digital
Sep 2020
ISPE Europe Conference
Sep 2020
Future Laboratory Informatics
Sep 2020
Pharma & Patient Europe
Sep 2020
EFMC International Symposium on Medicinal Chemistry (EFMC-ISMC)
Sep 2020
FWD Pharma
Sep 2020
Life Science Regulatory Information Summit
Aug 2020
International Conference on Epidemiology and Infection
Aug 2020
International Conference on Pharmacology and Pharmaceutical Medicine (ICPPM)
Aug 2020
The Ketamine Conference - A Molecular Masterclass
Aug 2020
European Congress on Vaccines R&D & Vaccination
Aug 2020
Hemophilia Drug Development (HDD)
Aug 2020
Medicinal Development of Cannabis and Cannabinoids
Aug 2020
European Congress on Pharmaceutical Sciences
Jul 2020
European Summit on Pharmacology and Toxicology
Jul 2020
International Conference on Pharmaceutical Analysis & Analytical Chemistry (Pharmaceutical Analysis)
Jul 2020
International Conference on Pediatric Pharmacology and Therapeutics
Jul 2020
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
Jul 2020
Biomanufacturing Congress
Jul 2020
International Conference on Pharmacology and Nanotechnology
Jul 2020
World Congress on Neuropharmacology
Jun 2020
Neuroscience Nursing
Jun 2020
Pharma Packaging and Labelling Europe
Jun 2020
International Congress on Pharmaceutical Biotechnology
Jun 2020
International Conference on Pharmaceutics & Novel Drug Delivery Systems
Jun 2020
Annual Congress on Pharmaceutics & Drug Delivery Systems
Jun 2020
Psychedelics Opportunity
Jun 2020
Bio International Convention (BIO)
Jun 2020
Market Access Latin America Leaders Forum
Jun 2020
Risk & Pharmacovigilance MasterClass
May 2020
Webinar on Pharmacology
May 2020
Predictive Analytics World Healthcare
May 2020
Meet on Euro Ethnopharmacology
May 2020
International Conference on Advanced Nanoscience and Nanotechnology
Apr 2020
Pharmaceutical Chemistry conference
Apr 2020
SMi`s Superbugs and Superdrugs Conference
Mar 2020
Death by CAPA - Does your CAPA Program need a CAPA
Feb 2020
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
Feb 2020
You have a BI Positive or Product Sterility Positive - Now What
Nov 2019
CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE
Sep 2019
Effective Standard Operating Procedure (SOPs) Development
Aug 2019
Design of Experiments for Non-Statisticians
Aug 2019
Sample Quality Control with Molecular Diagnostics
Aug 2019
Strategies for Speeding Up Formulation Development
Jul 2019
Process Validation - Overview of Why and How
Jul 2019
6 Most Common Problems in FDA Software Validation and Verification
Jul 2019
Updates to the EPA Final Rule for Hazardous Waste Pharmaceuticals and FDA-Approved Nicotine (P075)
Jul 2019
Toxic Impurities in Active Pharmaceutical Ingredients
Jul 2019
Basics of Testing Associated with Sterilization Validation and Routine Processing
Jul 2019
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
Jul 2019
Establishing FDA-Compliant Social Media Practices to Avoid FDA Actions
Jul 2019
Assay Validation for Clinical Diagnostics
Jul 2019
Scale-Up, Cycle Transfer, and Maximum Throughput Capability for Lyophilized Products
Jul 2019
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
Jun 2019
Demystifying the Canadian Drug and Health Products Regulatory Landscape
Jun 2019
Auditing Laboratories Conducting Assays Supporting Biologics
Jun 2019
FDA Off-Label Promotion Guidelines
Jun 2019
Pharmaceutical Compressed Air – Quality GMP Standards and Requirements
Jun 2019
Power Analysis for Sample Size Calculations
Jun 2019
CAPA Simplified - A one-form, easy-to-complete, method for simplifying your CAPA Process
Jun 2019
Using Learning Management Systems (LMS) to Develop Pharma Training - Rewards and Challenges
Jun 2019
Implementing a Compliant Stability Program for Biologics
Jun 2019
3-Hour Virtual Seminar on HIPAA Training for Compliance Officer
Jun 2019
Structuring and Auditing Physician Medical Director and Administrative Arrangements: Key Stark Law Considerations
May 2019
Supplier and Service Provider Controls: FDA Expectations
May 2019
Overcoming Obstacles of the Canadian Drug Regulatory Landscape
May 2019
New Elemental Impurities Tests for Pharmaceutical Products According to the New ICH Q3D and USP 232/233 Guidelines
May 2019
Documentation of Medical Necessity - Focus for OIG and other auditors
May 2019
ICH Q7 FDA Guidance - Its Structure, History, Application and Writer`s Intent
May 2019
FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs
May 2019
Exploring the FDA Refuse-To-Accept (RTA) Guidance for 510(k) Submissions
May 2019
Customer Relationship Management: Strategic Methods to Manage Relationships
May 2019
Root Cause Failure Analysis Closed Loop Corrective Action
May 2019
Latin America – Understanding Regulatory Compliance Requirements Across the Life Science Industry
May 2019
Validation and Use of Excel Spreadsheets in FDA Regulated Environments
May 2019
Quality by Design (QbD) in Pharmaceutical and Medical Device Manufacturing
May 2019
Excel Spreadsheets: Develop and Validate for 21 CFR Part 11 Compliance
May 2019
Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU`s MDD Requirements
May 2019
FDA Rules for Pharmaceutical Analytical Method Validation
May 2019
Compliance Measures for Case Managers
May 2019
3-Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry
May 2019
In-Depth Testing of Computer Systems Regulated by FDA
Apr 2019
Essentials of Validation - IQ, OQ, PQ
Apr 2019
Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities
Apr 2019
Continued Process Verification - A Systematic Approach
Apr 2019
Risk Management in Clinical Research
Apr 2019
Cybersecurity in Healthcare - How to Prevent the Next Attack
Apr 2019
3-Hour Virtual Seminar on Safety Audits and Pharmacovigilance (PV) Inspections
Apr 2019
Monitoring and Validation of Pharmaceutical Water Systems
Apr 2019
Lean Six Sigma and ISO 9001:2015
Apr 2019
HIPAA and Having a Compliant Front Office
Apr 2019
Practical Implementation of Pharmaceutical Quality Risk Management (QRM)
Apr 2019
Strategies To Prevent Manufacture And Distribution Of Substandard Medications
Apr 2019
HIPAA & The medical practice: Requirements for Privacy, Security and Breach Notification
Apr 2019
510(k) and PMA Refuse to Accept Policy
Apr 2019
Sterile Filtration of Pharmaceutical Products – Validation and Regulatory Requirements
Apr 2019
HIPAA and Ransomware: Protect Against Attacks and Violation Penalties
Apr 2019
FDA Regulations for Pharmaceutical Current Good Manufacturing Practice (cGMP)
Apr 2019
Why Can`t They get This Done? Addressing Executive Function Breakdowns in Children and Adolescents with ASD
Apr 2019
Current Trends in CyberSecurity Threats to Medical Devices
Mar 2019
QbD Approach to Analytical Method Lifecycle: Design, Development, Validation and Transfer
Mar 2019
FDA Inspections - Do`s and Don`ts
Mar 2019
EU and US GMP/GDP – Similarities and Differences
Mar 2019
Theory and Practice of Near-Infrared Spectroscopy
Mar 2019
GMPs for Medical Marijuana Production Operations
Mar 2019
CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers
Mar 2019
The Most Serious FDA 483s - How to Avoid Them
Mar 2019
3-Hour Virtual Seminar on FDA`s Scrutiny of Social Media Promotion
Mar 2019
Patient Rights, Medical Records and HIPAA - What You Need to Know as a Healthcare Provider
Mar 2019
The FDA Inspection: Preparation, Management, and Follow - up
Mar 2019
CMO Supplier Quality Agreements – How to Comply with New FDA and EU Guidelines for Contract Drug Manufacture
Mar 2019
Effective Pharmaceutical GMP Audits and Self-Inspections
Mar 2019
Water System Biofilm Control and Microbial Monitoring Myths
Mar 2019
505(b)(2) NDAs
Feb 2019
GDPR and Implications on Drug Development
Feb 2019
Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes
Feb 2019
Surviving an FDA Sponsor Inspection - Training for Success
Feb 2019
Project Management for Non-Project Managers
Feb 2019
Complaint Handling Best Practices - Compliance with FDA and ISO Regulations
Feb 2019
Validation and Use of Excel Spreadsheets in FDA Regulated Environments
Feb 2019
USP [1224] Transferring the Method to meet Regulatory Expectations
Feb 2019
Interdisciplinary Care Rounds: A Key Strategy for Improving Case Management Outcomes
Feb 2019
Virtual Seminar on Master Validation Plan - The Unwritten Requirements
Jan 2019
In-Depth Computer System Validation (CSV) for FDA Compliance
Jan 2019
QbD Development Process Evaluating Critical Steps
Jan 2019
Tips and Techniques for Handling Missing Data (Statistical Techniques)
Jan 2019
Current Regulatory Requirements for Aseptically Produced Products
Jan 2019
How to Prepare for an FDA Inspections?
Jan 2019
OOS Investigation & Root Cause Analysis
Jan 2019
Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration
Jan 2019
Medical Marijuana in the Workplace
Jan 2019
Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error
Jan 2019
FDA and EMA Global Labeling Challenges and Requirements
Jan 2019
Verification vs. Validation in Regulated Industries
Jan 2019
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements
Jan 2019
Validation and Use of Cloud Computing in FDA Regulated Environments
Dec 2018
Seasonal Influenza Vaccines- Current Concepts and Future Trends for Effective Immunization
Dec 2018
Statistical Quality Control in Pharmaceutical and (IVD Industries)
Dec 2018
Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents
Dec 2018
CMS Hospital Improvement Act Proposed Changes: Nursing, Medical Records, Infection Control, Antibiotic Stewardship Program, Restraints, QAPI
Dec 2018
Auditing for Microbiological Aspects in Pharmaceutical Manufacturing
Nov 2018
How to Write SOPs which are Compliant for Inspections for a GXP Compliance
Nov 2018
Data Integrity in the Pharmaceutical Industry
Nov 2018
Ensuring Integrity and Security of Laboratory Data
Nov 2018
Meet the Tougher U.S. FDA CGMPs
Nov 2018
Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing
Nov 2018
Human Error Prevention in Pharmaceutical Manufacturing
Nov 2018
Sterilization of Pharmaceutical Products and Medical Devices
Oct 2018
Effective Batch Record Review
Oct 2018
Pharmaceutical Dissolution Testing – Sampling and Assay
Oct 2018
Change Control Procedures in Regulated Industries
Oct 2018
Good Documentation Guideline (Chapter 1029 USP)
Oct 2018
Aseptic Process Overview and Validation
Oct 2018
Troubleshooting Ethylene Oxide (EO) Processes
Oct 2018
FDA Auditing Practices and the Top 10 Most Common Cited GMP Deficiencies
Oct 2018
Powerful Closed-loop CAPA - Meeting FDA Expectations
Oct 2018
Recent FDA Auditing Practices and the Top 10 Most Common Cited GMP Deficiencies
Sep 2018
cGMP Water Systems – Are You Ready for the FDA Inspection?
Sep 2018
FDA`s New Enforcement of 21 CFR Part 11
Sep 2018
Quality Agreements Made Easy
Sep 2018
How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
Sep 2018
Compliance for Risk Based Approaches for Clinical Trials
Sep 2018
CGMP controlled Raw Materials
Sep 2018
Marketing to Medicare or Medicaid Beneficiaries - What You Can and Cannot Do
Aug 2018
The Regulatory Expectations for Environmental Monitoring Programs
Aug 2018
Design Control Basics
Aug 2018
Deciding When to Submit a 510(k) for a Change to an Existing Device
Aug 2018
Building a Compliant Documentation and Training System
Aug 2018
FDA Compliant QC and QA Practices – Creating a Perfect, Audit-Ready QMS
Aug 2018
CMS Hospital CoP and TJC Telemedicine Standards, Telemedicine Credentialing and Privileging
Jul 2018
Opioid Abuse in the Workplace: Using Effective Drug Testing and Policies to Reduce the Pain of the Painkiller Epidemic
Jul 2018
Laboratory Investigations for Out of Specification Results
Jul 2018
Sunshine Act Reporting: Clarification for Clinical Research
Jul 2018
Pharma Water Systems - New Water Systems Project Details
Jul 2018
Root Cause Analysis (RCA) in the Laboratory - Addressing Non-Conformances
Jul 2018
Good Documentation Guideline (Chapter <1029> USP)
Jul 2018
CMS New Requirements of Participation - Phase 2 : Do you know what is required?
Jul 2018
Onboarding In A GMP Environment – Best Practices
Jul 2018
Forced Degradation Studies/ Biologics Stability Programs for Biopharmaceuticals
Jul 2018
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
Jul 2018
Central Nervous System (CNS) Drugs and Breastfeeding
Jul 2018
How to Make Sure Your Foreign Vendors are FDA Compliant and Stay that Way
Jul 2018
Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions
Jul 2018
Project Management for FDA-Regulated Companies
Jul 2018
Patients Suing Under HIPAA
Jul 2018
Develop a Compliant Validation Protocol and Analytical Procedures according to the FDA Guidance and USP Good Documentation Practices
Jul 2018
Understanding and Implementing USP [1058]: Analytical Instrument Qualification
Jul 2018
510(k) Documentation Best Practices for Software or Software Enabled Medical Devices
Jun 2018
Water System Investigation `How-To`s` and Example Case Studies
Jun 2018
Biocompatibility Testing; what you need to know
Jun 2018
Overview of Medical Device Regulation in Europe
Jun 2018
Stability Programs for Leachable Impurities
Jun 2018
HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms
Jun 2018
Introduction to Good Manufacturing Practices (GMP)
Jun 2018
Health Outcomes of Childhood ADHD - Impact on Life Expectancy and Clinical Implication
Jun 2018
Oversight of CROs-Vendors-CMOs
Jun 2018
Diagnosing and Treating Anxiety Disorders
Jun 2018
Why and How - Verification of Compendial Methods - USP [1226]
May 2018
Gaining and Re-Establishing Control of Your Cleanroom
May 2018
Setting Specifications for Drug Substances and Drug Products
May 2018
Document Control and Change Control Process in GxP/GMP Environment
May 2018
GMP Expectations for Products Used in Early Phase IND Studies
May 2018
Health Product Marketing authorization in Brazil - Documentation, Approval Process, Labeling, Advertising and Post Market Vigilance
May 2018
How to Comply with 21 CFR 11 Requirements for Electronic Medical Records
May 2018
Medical Device Single Audit Program (MDSAP) Preparation
Apr 2018
Software Validation for the New FDA Inspections
Apr 2018
Dietary Supplements CGMPS - 21 CFR 111 Compliance
Mar 2018
Analytical Method Validation
Mar 2018
FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program
Mar 2018
Ensuring Data Integrity in Method Validations
Feb 2018
Bioavailability and Bioequivalence Studies Submitted in NDAs and INDs for Orally-Administered Drug Products
Feb 2018
Acceptance Activities in FDA QSR
Feb 2018
Management Control - Underutilized and Underappreciated
Feb 2018
Technical Writing Essentials
Feb 2018
The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization
Feb 2018
Unique Device Identification (UDI) - GUDID: Final Rules, Implementation and Compliance
Feb 2018
Risk Management in Clinical Trials
Feb 2018
Good Manufacturing Practices for Active Pharmaceutical Ingredients per ICH Q7
Feb 2018
Breaking the Cycle of Parasitic Infections
Feb 2018
Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigation
Feb 2018
How Accurate Adverse Event Reporting is the Key to Subject Safety of Approved Drugs
Feb 2018
Validation of FDA-Regulated Computer Systems
Feb 2018
Advances in Food Allergy & Hypersensitivity Research: Triggers and Treatment
Jan 2018
Trial Master File for Clinical Data Systems Regulated by FDA
Jan 2018
The Value of a Human Factors Program
Jan 2018
FDA Regulation of Dietary Supplements
Dec 2017
Excel Spreadsheets - Step-By-Step Instructions for Compliance
Dec 2017
Effective Strategies to Manage Validation In Conformance With The Pharmaceutical Quality System
Dec 2017
Integration of ERP and Legacy FDA-Regulated Systems
Dec 2017
Why are we Seeing More Independent Data Safety Monitoring
Dec 2017
Analytical Method Validation Under Good Laboratory Practices - GLPs
Dec 2017
Targeting Cancer: New developments in cancer therapeutics
Nov 2017
Compliance Requirements for Compounding Pharmacies Based on USP Chapters 795, 797, and 800
Nov 2017
World Clinical Medicine & Collaboration Forums
Oct 2017
Laboratory Instrument Qualification
Oct 2017
Lean Validation: Leveraging the NIST Cybersecurity Framework For Computer Systems Validation
Oct 2017
Managing Your FDA '483' Inspectional Observations
Oct 2017
21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
Oct 2017
GLP Quality System Essences and Comparison with GMP
Oct 2017
Effective Training Practices for FDA Compliance
Sep 2017
Best Practices for an Effective Cleaning Validation Procedures
Sep 2017
Advances in Cellular Therapy
Sep 2017
Excel Workbooks and FDA Device Regulations
Aug 2017
Moving from GMPs to the Pharmaceutical Quality System
Aug 2017
Laboratory-Developed Tests: Why does FDA think they can Regulate them, and why do others think they Cannot
Aug 2017
How to Prepare for and Host a FDA Inspection and Respond to 483`s
Aug 2017
Effective Supplier Qualification Program
Aug 2017
Pharmaceutical Quality Risk Management (QRM) Overview
Jul 2017
Understanding Aseptic Technique and Cleanroom Behavior
Jul 2017
Personnel Training to Assure FDA and ISO Compliance
Jul 2017
An Introduction to Risks associated with Extractables, Leachables & Elemental Impurities in cGMP Manufacturing: A Project Managers Perspective
Jul 2017
Statistical Concepts of Process Validation
Jul 2017
Writing Effective Standard Operating Procedures and Work Instructions
Jun 2017
Proactive Internal Auditing -The Key to Establishing, Maintaining, and Improving Quality Systems
Jun 2017
Advancing Alzheimer`s Research: Characterisation, Diagnosis & Treatment
Jun 2017
Improving Process Stability and Capability - Tips, Traps and Guidance
Jun 2017
FDA Policy and Goals Regarding the 483 Response
Jun 2017
FDA`s Expedited Development and Approval Programs: Taking the Mystery out of Expedited Approvals
May 2017
FDA’s 21 CFR Part 11 Add-on Inspections
May 2017
Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data
May 2017
Medical Device Employee Training -Requirements and Implementation tips
May 2017
FDA Scrutiny of Promotion and Advertising Practices
May 2017
How FDA Trains Its Investigators to Review CAPA, and What You Can do to Prepare
May 2017
Best Practices for Preparation for, Behavior during, and Response to an FDA Inspection
Apr 2017
The Obesity Epidemic: Discussing The Global Health Crisis
Apr 2017
Efficient and Effective FDA and ISO Management Reviews
Apr 2017
Good Documentation Practices for FDA-Regulated Computer Systems
Apr 2017
New GS1 US Guideline - Pharmaceutical Industry Prepares for DSCSA Item-Level Traceability Requirements
Apr 2017
Inclusion of LGBT Employees in Healthcare: Navigating Policies, Procedures, and Practices
Apr 2017
Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects
Apr 2017
Pharma Analytics – I Have All These Data, Now What Do I Do?
Mar 2017
HIPAA and Health IT
Mar 2017
Data Analysis in QSR
Mar 2017
Avoiding Critical R&D Formulation/Drug Delivery Errors
Mar 2017
FDA & CFIA 2016 Regulatory Changes/Updates
Mar 2017
21 CFR Part 820 Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration
Mar 2017
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration
Feb 2017
Ageing
Feb 2017
CMS Hospital Improvement Act Proposed Changes: Nursing, Medical Records, Infection Control, Antibiotic Stewardship Program, Restraints, QAPI and much more!
Feb 2017
Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations
Feb 2017
Microsoft Excel Series - Part 3: Beyond IF and Excel Macros
Feb 2017
21 CFR Part 11 compliance for Electronic Medical Records
Feb 2017
Clinical Trial Monitoring: A Sponsor Responsibility
Feb 2017
Laboratory Inspection Readiness - Implementing GMPS for the Pharmaceutical Laboratory
Feb 2017
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico
Feb 2017
Microsoft Excel Series - Part 2: Learn More about Macros
Feb 2017
Innovations in wound healing and wound management
Feb 2017
Disaster Recovery (DR) and Business Continuity Planning (BCP) Best Practices for an FDA-Regulated Environment Increasingly Challenged by Cyber Attacks and Other Threats
Jan 2017
USP 797/USP 795: Reviewing the Proposed Changes & How to Create and Manage a State of Control in Pharmacies
Jan 2017
The Sunshine Act: Reporting for Clinical Trials
Jan 2017
Microsoft Excel Macros-4-Part Series: Your Key to Success In The Modern Business World
Jan 2017
Microsoft Excel Series - Part 1: Shake Hands with Macros
Jan 2017
FDA Regulation of Combination Products
Jan 2017
The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND: Comparing the Content and Agency Expectations
Jan 2017
Bacteriophage
Jan 2017
Recalls, Removals, and Market Corrections in Compliance with FDA and ISO Requirements
Jan 2017
Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results
Jan 2017
Implementation of Risk Evaluation and Mitigation Strategy (REMS) Programs in a Health System
Jan 2017
Implementation of the Generic Drug Labeling Rules
Jan 2017
HIPAA Breach Notification Rule - What you must do to Comply
Jan 2017
The New FDA-Product Approval, Inspection, and Enforcement
Jan 2017
Effective Corrective and Preventive Action Program (CAPA): The Role of Corrective Action and Preventative Action in Your Quality Management System
Jan 2017
Process Capability Analysis Of Extremely Non-normal Data
Jan 2017
Navigating the New European Clinical Trial Regulation (EUCT Regulation 536-2014)
Jan 2017
Corrective and Preventive Action (CAPA)
Jan 2017
New HIPAA Rules - Meeting Requirements for New Patient Rights and New Restrictions on Disclosures
Jan 2017
The Science of Pain and its Management
Dec 2016
Construction of the European Drug Master File (EDMF) for Regulatory Agencies - Webinar by GlobalCompliancepanel
Dec 2016
Product Risk Management Under ISO 14971:2007 and ICH Q9
Dec 2016
510(k) Preparation with New Released FDA Guidance on Product Modifications
Nov 2016
Understanding European Filing and Registration Procedures for Drug Approval
Nov 2016
Determining Sample Size: How to Ensure You Get the Correct
Nov 2016
Developing antibiotic alternatives: A discussion of new approaches to overcoming antimicrobial resistance
Nov 2016
HIPAA Security & Privacy Risk Analysis- OCR Audits
Oct 2016
Vaccine Antigen Delivery: new approaches to vaccine development
Oct 2016
FDA’s New Draft Guidance on Data Integrity for CGMP Compliance
Oct 2016
Implementation of Document Control Systems
Oct 2016
Design and Execution of Stability Studies for Biologics
Oct 2016
Auditing Clinical Trials for Good Clinical Practice (GCP) Compliance
Oct 2016
FDA Vs Health Canada
Oct 2016
FDA`s Update on Elemental Impurities According to the new ICH Q3D and USP 232/233 Guidelines - Are you ready?
Sep 2016
Biopharmaceuticals as Therapeutic Agents Product and Process Development and Evaluation
Sep 2016
Technical Writing for Medical Products: SOPs, Investigations and Change Records
Sep 2016
GCP: The IND, How to Gain Approval for Clinical Trials in the USA
Sep 2016
Quality Metrics Program: FDA Challenges and Requirements including the New `Quality Metrics Technical Conformation Guide` Released
Sep 2016
Understanding the USP and FDA Functions in the Pharmaceutical Industry
Sep 2016
Vaccines and Immunotherapeutics
Sep 2016
Defining and Managing Protocol Deviation/Violation/Exception
Sep 2016
FDA and CFIA-Overview of Proposed Regulations - Let`s Get Updated
Sep 2016
Medical Device Tracking: Latest FDA Update and Expectations
Sep 2016
Reducing Drug and Device Batch Release Times: Improving your BPR/DHR Review and Assessment
Sep 2016
How to use Risk Based Process Safety`s skills to be in compliance with ICH-Q9 `Quality Risk Management` in the Pharmaceutical Industry
Sep 2016
Business Continuity or Disaster Recovery Planning
Aug 2016
U.S. OTC Drug Labeling Regulations & Requirements
Aug 2016
Lyophilization: What you Need to Know, Validation and Regulatory Approaches
Aug 2016
Preparing Compliant eCTD Submissions: Are you prepared for the upcoming FDA mandate on e-submissions
Aug 2016
Clinical Trials be at Risk for Potential Fraudulent Billing. Conducting a Billing Risk Assessment and Coverage Analysis are Essential for Proper Billing.
Aug 2016
How to do a Risk Analysis
Aug 2016
FSMA Gives FDA Recall Authority Over Adulterated Food and Broadens Standards for Food Detention
Aug 2016
How to Prepare for Increased HIPAA Enforcement
Aug 2016
New CMS CoP Regulations for Managing Grievances and Complaints: What Hospitals Should Know about the CMS and Joint Commission and DNV Standards
Aug 2016
Are You Ready For The FDA`s Mandate Requiring Electronic Submission Conformance to SEND and SDTM?
Aug 2016
Health Canada`s Regulations on Natural Health Products vs. FDA`s Dietary Supplement Regulations
Jul 2016
FDA`s Emerging Signals Guidance: Reporting Medical Device Safety Warnings
Jul 2016
FDA Issues Draft Guidance for 3D Printed Medical Devices
Jul 2016
Human Factors/Usability Based on ISO 62366
Jul 2016
Process Validation - Current Industry Practices and FDA Guidance Document Review
Jul 2016
Integrating the GMPs with the Pharmaceutical Quality System (ICH Q10)
Jun 2016
Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries
Jun 2016
Analytical Method Validation under Good Laboratory Practices (GLPs)
Jun 2016
Introduction to Dissolution Method Development & Validation
Jun 2016
Post-marketing Adverse Event Reporting for Non-prescription Human Drug Products Marketed Without an Approved Application
May 2016
Adverse Event Reporting: Site and Sponsor Reporting Requirements for Investigational Products
May 2016
GMPs for OTC and Cosmetic Products - US and Global Requirements
May 2016
Lifecycle Approach to Analytical Methods: Incorporating QbD Principles into Method Development, Validation and Transfe
May 2016
GMP Complaint Systems and Product Recalls
May 2016
Implementing Validation and Qualification - Annex 15 and FDA Requirements
May 2016
Validation of a HPLC/UPLC Methodology
May 2016
USP [800] - Guidelines for Safe Handling of Pharmaceuticals
Apr 2016
The Importance of the Investigator Responsibilities and Legal Commitments in Drug and Device Clinical Research in Achieving a Clean Audit
Apr 2016
Packaging and Labeling for Commercial and Clinical Products
Apr 2016
Medical Coding, Billing and Documentation
Apr 2016
How Fixing FDA Compliance Problems (Remediation) Aligns with the 5 Stages of Grief
Apr 2016
How the FDA & FTC Regulate Advertising & Promotion of Drugs & Dietary Supplements
Apr 2016
Integration of ERP and Legacy FDA-Regulated Systems
Apr 2016
Mathematics of Terminal Sterilization - Probability of Survival Approach -vs- Overkill Approach
Mar 2016
Root Cause Analysis - The Heart of a Successful CAPA Program
Feb 2016
Pharma Marketing Online Conference: Building Better Customer Journeys
Feb 2016
Creating Effective SOP for Regulatory Compliance
Jan 2016
Investigational Device Accountability
Jan 2016
Cleanroom Monitoring & Maintaining a Quality Environment : Overcoming USP [797] Common Non-Compliance Issues
Jan 2016
Drug Master Files: New Implications under GDUFA
Jan 2016
Toyota Kata - Wax On, Wax Off (in partnership with ASQ Lean Enterprise Division)
Jan 2016
Creating and Maintaining a GMP Quality System
Jan 2016
Process Robustness: The New FDA Paradigm
Jan 2016
FDA`s Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List
Jan 2016
FDA`s New Enforcement of 21 CFR Part 11
Jan 2016
FDA Inspection Lessons Learned: Lack of Trial Oversight
Jan 2016
How to Properly Monitor Process and Performance of Pharmaceutical Solid Dosage Equipment
Jan 2016
How to Respond to an FDA Investigation: What happens when the FDA threatens to shut you?
Jan 2016
Pharmaceutical Water Use and Monitoring
Dec 2015
Registration & Listing, FDA Inspection Strategies and Compliance Initiatives - Medical Device
Dec 2015
The Most Common Coding Errors and How to Avoid them
Dec 2015
Top 10 Writing Mistakes for Pharmaceutical Consultants and Technical Writers
Dec 2015
Paediatric Drug Development - Adult Data and Relevant FDA Laws
Dec 2015
Objectionable Microorganisms: Considering the Risk
Dec 2015
FDA Regulations for Marketing OTC Drugs in the U.S.
Dec 2015
Tougher U.S. FDA cGMP Compliance Audits - When You`re Not Ready
Nov 2015
Webinar on EMTALA - Emergency Medical Treatment and Active Labor Act Explained
Nov 2015
Generic Drug Product Development (ANDA) and Paragraph IV Filing Strategy (Exclusive to the US Market)
Nov 2015
Mastering 2013 Excel Functions and Formulas
Nov 2015
ICH-FDA Good Clinical Practice – Managing Clinical Trials
Nov 2015
Building a Vendor Qualification Program for FDA Regulated Industries
Nov 2015
Development regulatory affairs for Oncology Medicinal Products
Oct 2015
Product Stability Testing Program - Designing and Sustaining New and Existing Programs
Oct 2015
How to Survive a DEA Inspection Series: Controlled Substances and Hospital Pharmacy
Oct 2015
Drug Product-Injury Litigation: Effective Use of Medical Information and the Scientific Literature in Building a Strategy for Defense
Oct 2015
TM`s world drug discovery online conference
Oct 2015
A look at 510(k) changes
Oct 2015
Regulatory Submissions
Oct 2015
Combination Products: FDA`s Final Rule for GMP Requirements and Introduction and Expectations for `Combo` Products
Oct 2015
Developing an Effective CAPA Program for GMP Operations
Oct 2015
Differences between Device Research and Drug Research
Oct 2015
Risk Management in Clinical Trials
Oct 2015
Extending Drug`s Life
Oct 2015
Establishing an FDA-Compliant UDI System
Oct 2015
Orphan Medicinal Product Designation in the EU
Sep 2015
Product Risk Management - ISO 14971:2007
Sep 2015
Calibration and Qualification in Analytical Laboratories
Sep 2015
Budgeting for Clinical Trials: Understanding Costs of a Study and Which Costs Sponsors are Responsible to Cover
Sep 2015
Conducting Effective Quality Audits: Beyond Audit Checklists
Sep 2015
The Role of FDA in Health Care Software Regulations and Development
Sep 2015
US Drug Supply Chain Security Act - Serialization & Validation for Track & Trace Compliance
Sep 2015
Developing the Quality System from Scratch
Sep 2015
FDA 510(k) Requirements, Submission, and Clearance: Best Practices
Sep 2015
Application of Lean Six Sigma Methodology for Regulated Industries
Sep 2015
Auditing QC and Contract Laboratories for GMP Compliance
Sep 2015
Steering Clear of DOJ’s Most Likely to Be Caught List
Sep 2015
FDA`s enforcement of 21 CFR part 11 compliance
Sep 2015
How to Transition from Paper to Electronic Records in a Regulatory Environment
Sep 2015
Basic Requirements for Developing IQ and OQ Protocols
Sep 2015
Understanding the Implications of FDA 483s and Actions to Avoid Further Regulatory Actions
Sep 2015
CAPA Investigations - Tools for a Compliant and Effective Investigation Process
Sep 2015
Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies
Aug 2015
Meeting Annual U.S. FDA cGMP Training Requirements
Aug 2015
Orphan Drugs: the Conundrum- Clinical Research Trials
Aug 2015
Licensing and Regulatory Compliance in Mail Order Pharmacy
Aug 2015
Supplier Quality Agreements - Essential for Suppliers of Many Outsourced Processes
Aug 2015
Failure Mode and Effects Analysis for Design Improvement and Design Control
Aug 2015
Understanding FDA Regulations and Role in Opioid Pain Management
Aug 2015
How to Survive an FDA Inspection
Aug 2015
Paediatric Drug Development - Adult Data and Relevant FDA Laws
Jul 2015
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Configuration
Jul 2015
DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions
Jul 2015
USP Hot Topics: What`s Hot Now and How to Track Coming Changes and Influence USP
Jul 2015
Validation of Complex Cell-Based Potency Methods
Jul 2015
The Future of OTC Drug Regulation and the Monograph Process
Jul 2015
Canadian Site Licence Applications for Dietary Supplements. - By Compliance Global Inc
Jul 2015
Canadian Establishment Licenses: Drugs, Supplements and Medical Devices
Jul 2015
Drug Diversion by Healthcare Personnel -Prevention Program to Protect Your Patients, Employees, and Organization
Jul 2015
Best Practices for Quality Risk Management for the Pharmaceutical Industry
Jun 2015
Software Verification and Validation in Medical Industry
Jun 2015
South East Asia Regulatory Compliance for Life Science Products, Live Webinar
Jun 2015
How to Develop PAT Approach-Regulatory Compliance
Jun 2015
A CAPA Primer - Elements of a CAPA Program
Jun 2015
Writing Evaluation Reports-How to Write Evaluation Report
Jun 2015
U.S. FDA`s New Strategic Priorities 2014 - 1018 ()
Jun 2015
Learning from Recent FDA Warning Letters Related to Part 11 and Computer Validation
Jun 2015
HIPAA and Social Media - How They Can Coexist in Compliance
Jun 2015
Quality by Design: Establishing a Systematic Approach to Pharmaceutical Development
Jun 2015
Conducting Observational Studies in US, Canada and Europe
Jun 2015
How to Most Effectively Prepare for and Manage FDA Inspection: Best Practices
Jun 2015
Monitoring Plans: 10 Rules of Effective Writing of Monitoring Plans
May 2015
The FDA Inspection: Preparation, Management, and Follow-Up
May 2015
Establish and Maintain an Effective Supplier Qualification Program
May 2015
Insulin Therapy
May 2015
Ensuring Data Integrity for FDA/EU Compliance
May 2015
CAPA, Failure Investigation and Root Cause Analysis - FDA Expectations
May 2015
Optimal Resource Allocation and Capacity Planning for Biopharma and CRO
May 2015
Practical Application of HIPAA Risk Analysis
May 2015
Managing FDA After a Bad Inspection
May 2015
Complaint Handling in Compliance with FDA and ISO Regulations
May 2015
Regulatory Aspects of Advanced Therapy Medicinal Products in the EU
May 2015
DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions
May 2015
Part 2 - Quality Management System effectiveness: ICH Q10 principles, impact of failure on COGS, principles of QRM, what you can impact in reactive versus proactive
May 2015
FDA Guidance on RUO (Research Use Only)/IUO (Investigational Use Only) Products
May 2015
ICH Q10 - Reading the Crystal Ball How will the Pharmaceutical Quality System impact the cGMPs
Apr 2015
ICH Q10 - Moving From GMPs To A Pharmaceutical Quality System
Apr 2015
Process Analytical Technology (PAT) – A Practical Approach
Apr 2015
HIPAA Audit Program Update
Apr 2015
Change Control - Key to Successful cGMP Compliance
Apr 2015
UDI Implementation
Apr 2015
South East Asia Regulatory Compliance for Life Science Products - Hong Kong, Taiwan, Thailand, Singapore, Malaysia and Vietnam
Apr 2015
Use Risk Assessment to Reduce Validation Time for 21 CFR Part 11
Apr 2015
Is it Method Verification or Validation, or Just Semantics?
Apr 2015
Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts
Apr 2015
Medical Packaging Validation Strategies, Planning for Success
Apr 2015
Writing and Implementing Statistical Analysis Plans (SAPs) - Domestic and International Guidance under ICH E9
Apr 2015
Issues with Risk Assessments for Cross Contamination of OSD Facilities
Apr 2015
The Need and Role of Standard Operating Procedures in the Pharmaceutical and Medical Device Industries
Apr 2015
Combination Drug/Device Products CGMPs - Final Rule
Apr 2015
The Values and Benefits of Medical Device Reporting Compliance
Apr 2015
China: Compliance Processes for Life Science Products (Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations)
Apr 2015
HIPAA and BYOD - Portable Devices and Enforcement
Mar 2015
Health Canada’s Enforcement of the Regulatory Requirements for the Manufacture, Advertising and Sale of Pharmaceuticals, Medical Devices and Natural Health Products
Mar 2015
Product Standards, Menthol and FDA`s Deeming Regulation
Mar 2015
Biological Facility Design for Compliance
Mar 2015
Biomedical Software Regulation
Mar 2015
Designing Effective and Efficient Extractables or Leachables Studies for Biologics
Mar 2015
New Part 11 Guidance for Clinical Trials: What This Means for You
Mar 2015
Dietary Supplement Current Good Manufacturing Practices (cGMP)
Mar 2015
Avoid Warning Letters in View of the U.S. FDA`s Stated Goal
Mar 2015
Current Concepts and Challenges in Cloud Compliance
Mar 2015
How to Successfully Manage an FDA High Risk Inspection
Mar 2015
Better Alternatives to Sampling Plans
Mar 2015
Institutional Review Boards (IRBs): The Changing Landscape and the Effect on the Conduct of Clinical Research
Mar 2015
Monitoring Impurities in Pharmaceutical Products - ICH Q3 requirements
Mar 2015
How to Avoid an FDA Warning Letter with a Strong CAPA Program
Mar 2015
Complaint Handling and Management: From Receipt to Trending
Feb 2015
The 6 Most Common Problems in FDA Software Validation and Verification
Feb 2015
Stability Program to Support Shipping and Distribution of Drug Products
Feb 2015
Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials
Feb 2015
Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
Feb 2015
Clinical Trial Liability Lawsuits
Feb 2015
Blinding of Investigational Materials
Feb 2015
21 CFR 11 Compliance for Excel Spreadsheet
Feb 2015
The FDA 510(k) and Q-Submission: Best Practices
Feb 2015
Changing Supplier Controls Requirements
Feb 2015
Benchmark for Cleaning Validation
Jan 2015
A Bulletproof, Cost-efficient Supplier Management Program
Jan 2015
Updates in Diabetes Management
Jan 2015
A Systematic Approach To Writing Effective Standard Operating Procedures (SOPs)
Jan 2015
EU Clinical Trial Regulation: New Requirements
Jan 2015
What is the harm in that? Risk Management 101
Jan 2015
U.S. FDA`s Strategic Priorities - and Beyond
Jan 2015
The FDA Drug Approval Process
Jan 2015
Pharmaceutical and Chemical Classification under the Harmonized Tariff Schedule
Jan 2015
Regulatory Updates in China: APIs & Dossier Submissions
Dec 2014
Developing an Efficient Relationship with FDA
Dec 2014
Cosmetics and the Science of Beautiful Skin
Dec 2014
Clinical Trial Recruitment Methods and Metrics
Dec 2014
What are Serious Adverse Events & How do I Handle SAEs?
Nov 2014
How to Develop an Effective Compliance Program
Oct 2014
Legacy System Replacement in an FDA-Regulated Environment
Oct 2014
Pharmaceutical and Chemical Harmonized Tariff Schedule Classification
Oct 2014
Care Transitions Models and the Role of the RN and APN
Oct 2014
Strategies and Tactics for Retrospective Denied Claims Appeals
Oct 2014
Texting and E-mail with Patients — Communicating Within the HIPAA Rules
Oct 2014
Implementing the Best Practices for FDA Inspection Preparation and Management
Oct 2014
HIPAA Enforcement - Focus on Breaches and Random Audits
Oct 2014
HIPAA Breach Notification - Preventing and Responding to Health Information Breaches
Sep 2014
Workplace Violence Personal Safety Training for Healthcare
Sep 2014
FDA Regulations for Food, Drugs, Biologics, Cosmetics, and Medical Devices Including IVDs
Sep 2014
Pursuance of FDA draft guidance on analytical method validation for Drugs and Biologics
Sep 2014
FDA Recordkeeping Requirements
Aug 2014
Controlled Document System for a Life Sciences manufacturing plant utilizing the principles of Lean Documents and Lean Configuration
Aug 2014
Maintaining a Validated State – PV, PM and Statistics associated with Current Regulation
Aug 2014
How to handle a regulatory inspection to avoid FDA-483 issues
Aug 2014
Role of Analytical support during various audits - Regulatory and Non Regulatory
Aug 2014
How to do a Risk Analysis
Aug 2014
Batch Production Record and Device History Record Review and Quality Assessment
Aug 2014
How to Properly Handle HIPAA Security Incidents and Actual Breaches
Aug 2014
Analyzing Your Biggest Data - Practical Text Mining for FDA-regulated Companies
Aug 2014
ADR Management and Reporting
Jul 2014
Auditing, Qualifying and Controlling, Suppliers and Contractors for Pharmaceuticals and Medical Devices (Purchasing Controls)
Jul 2014
Know your regulators: Pharmaceutical Regulatory Agencies and Organizations around the World: Scope and Challenges in Drug Development
Jul 2014
FDA’s Part 11 – Enforcement Trends and Affordable Steps to Take Today
Jul 2014
Planning And Strategy Development For Managed Care Contract Renewals
Jul 2014
Cleaning, Maintenance and Calibration Programs: Critical Programs but Often Overlooked
Jul 2014
How to Host Regulatory Audits (FDA, EU and Health Canada)
Jul 2014
HIPAA Fundraising: What You Need to Know, What You Need to Do
Jul 2014
CAPA Training and Causes of Warning Letters due to Lack of Comprehension
Jul 2014
Conducting an Effective Quality System Management Review
Jul 2014
21 CFR Part 11 Add-On Inspections by the FDA
Jul 2014
Analyzing Your Biggest Data - Practical Text Mining for Regulated Companies
Jul 2014
Basic Components of Establishing Quality Agreements
Jul 2014
How to Decide which HIPAA Policies You Need to Adopt
Jul 2014
Risk Analysis: How to Do it Right under HIPAA and HITECH
Jul 2014
Preparing for an FDA API GMP Inspection
Jul 2014
Supplier Qualification Audit, A Risk Based Approach
Jul 2014
Integrating Risk Management into the CAPA System
Jul 2014
GMPs and Adulteration - Understanding FDA Regulation of Cosmetics
Jul 2014
Effective Contamination Control in Biopharmaceutical Manufacturing
Jul 2014
Developing Biosimilars in Emerging Markets: Regulatory and Clinical Considerations
Jul 2014
HIPAA Regulations and the New OCR Guidance Memos: Cracking the Code
Jun 2014
Drug Discovery & Development (DDD)
Jun 2014
CAPA Training and Causes of Warning Letters due to Lack of Comprehension
Jun 2014
Preparing for FDA BIMO Inspection and Management
May 2014
Establishing a Medical Device Complaint Handling System integrated with a UDI System
May 2014
Submitting FDA Electronic Regulatory Filings – Drug Establishment Registrations and Drug Listings
May 2014
FDA Warning Letter Close-Out Program
May 2014
Meet FDA Expectations for a Tougher Supplier Audit Program
May 2014
China: Compliance Processes for Life Science Products (Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations)
May 2014
HIPAA Risk Analysis - Techniques to Find and Manage Security Risks
Apr 2014
US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus
Apr 2014
Adverse Event Reporting Compliance:The Key to Safe Drug Development / Subject Safety
Apr 2014
The U.S. FDA`s CAPA
Apr 2014
Establishing an Internal Audit Program of the Quality Management Systems Pursuant to ISO 13485 and 21 CFR Part 820
Apr 2014
Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration
Mar 2014
How To Translate Academic and Discovery Assays Into GLP Compliant Assays
Mar 2014
Establish Change Control for Pharmaceutical Stability Program
Mar 2014
Ensuring 21 CFR 11 Compliance at Suppliers
Mar 2014
Understanding ISO 13485 vs. ISO 9001 for Successful QMS in Medical Device Industries
Mar 2014
Key Regulatory Documents: Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) and Design Dossier
Feb 2014
Learning from FDA Warning Letters
Feb 2014
ICH Q10 Pharmaceutical Quality System
Feb 2014
Good Documentation Practices for Clinical Trials
Feb 2014
The Sunshine Act - Are You Prepared? The Reporting Deadline is Approaching Quickly!
Jan 2014
HIPAA Enforcement and Compliance Audits: What the auditors want and how to be ready before they call
Jan 2014
Using SharePoint as a Technology Platform for 21 CFR part 11 - A Case Study
Jan 2014
Clinical Trial Design for Personalised Medicine Webinar
Nov 2013
Remediating Pharmaceutical Water System Biofilm - What to Do After It Gets Ahead of You
Nov 2013
Social Media and Marketing FDA Regulated Products
Nov 2013
FDA vs. EU Inspections - How to Prepare and What are the Differences
Nov 2013
Annual Digital Marketing Strategies for Patient Outreach
Nov 2013
Project Management for Computer Systems Validation
Nov 2013
Corrective and Preventive Actions(CAPA) - 8 Steps to Achieve Compliance
Nov 2013
Thorough and Complete Investigations and Follow-up - A Current Regulatory Expectation
Oct 2013
Study to Support Shipping and Distributing Pharmaceutical Products
Oct 2013
Creating a Good Design History File (DHF) for Audit Success
Oct 2013
Charging for Investigational Drugs: Current Application of 21 CFR Part 312 and the Expanded Access Rules
Oct 2013
Falsifying Data in clinical trials. What to report?
Oct 2013
Water System Mythology: Common False Beliefs for Microbial Control and Monitoring
Oct 2013
Pharma Market Access & Regulatory Affairs in China
Oct 2013
Residual Solvents - Understanding the Requirements and Practical Strategies for Compliance
Sep 2013
Effective CAPAs: How to Avoid Scrutiny in FDA’s Latest Area of Focus
Sep 2013
FDA`s new enforcement initiative – Strategic Software Validation Planning for Executives and Managers
Aug 2013
Regulatory Differences Between Biopharmaceutics and Medical Devices
Aug 2013
Oncology Trials Outsourcing
Jul 2013
CAPA – The Heart of Your Quality System
Jul 2013
Supplier Management – Do you comply with the latest FDA and ISO 13485 requirements
Jul 2013
Optimal capacity planning and resource allocation for a portfolio of clinical trials
Jun 2013
The Future of Off-Label Marketing After the Caronia Decision
Jun 2013
FDA and Social Media - How to Promote your Products Using Web 2.0 in Compliance with FDA and FTC Laws and Regulations
Jun 2013
Introduction to Bioequivalence and Therapeutic Equivalence
Jun 2013
Shared facilities and the move to science based risk assessments
Jun 2013
Clinical trial regulations, GCP compliance and FDA inspections
Jun 2013
Serious Product Quality Problems – Dealing with the Press and the Public
Jun 2013
Key Issues in FDA & FTC Regulation of Dietary Supplements
May 2013
FDA Warning Letter Closeout Program
May 2013
Complaint Systems – The Essential Requirements
May 2013
The US FDA Quality System Regulation (QSR) – What Every Exective and Senior Manager Must Know
May 2013
e-Submissions & Data Standards for FDA (eCTD, CDISC, HL7)
May 2013
FDA-Compliant Medical Device Reporting (MDR)
Apr 2013
e-Submissions & Data Standards for FDA (eCTD, CDISC, HL7)
Apr 2013
Bridging the Gap: Co-Development of Targeted Therapeutics and Companion diagnostics in the US and EU
Apr 2013
Interactive Response Technologies for Clinical Trials
Apr 2013
Software Verification and Validation Planning to Meet FDA Requirements
Apr 2013
Overview of Combination Product Development for Pulmonary Drug Delivery
Apr 2013
Understanding Biofilm and Controlling It in Pharmaceutical Water Systems
Apr 2013
Best Practices for Preparation for, Behavior during, and Response to an FDA Inspection
Apr 2013
China: Compliance Processes for Life Science Products: Company Establishment, Clinical Trials, Registrations - Webinar By GlobalCompliancePanel
Apr 2013
Dietary Supplements - Regulatory Compliance Requirements, Product Claims, Labeling Issues and FDA Updates
Apr 2013
Container Closure Systems for Liquid and Lyophilized Products
Apr 2013
Dietary Supplements Labeling - Avoiding Claims that Invite Scrutiny and Penalties
Apr 2013
How to Make GMP Training Fun and Engaging
Apr 2013
Medical Devices: Designing and Implementing a Reimbursement Strategy Geared Toward CMS Reimbursement Approval
Apr 2013
Best Practices for Conducting OOS Investigations (in Pharmaceutical Laboratories)
Apr 2013
DHF, DMR, DHR and TF - Regulatory Documents Explained
Apr 2013
Statistics for Quality Control and Process Validation: Statistical Process Control (SPC) for Variable Data
Apr 2013
510(k): Format and Contents
Apr 2013
Auditing the QC Microbiology Laboratory for FDA Compliance
Apr 2013
Complaint Handling in Compliance with FDA and ISO Regulations
Apr 2013
Key Factors to develop an effective CAPA system
Apr 2013
New EU Pharmacovigilance Directive and Regulations
Apr 2013
3-hr Virtual Seminar: Annual ICH GCP Refresher Course
Apr 2013
Effective, Risk Based Implementation of the Quality Systems
Apr 2013
Design of Experiments in Biotechnology Analytical Development
Apr 2013
Ten-Step Process for COTS Computer System Validation - Reduce Time and Costs - GlobalCompliancePanel
Apr 2013
FDA QSR Acceptance Activities - Webinar By GlobalCompliancePanel
Apr 2013
Designing a Clinical Protocol for Vaccine Clinical Trial
Apr 2013
FDA Inspections - How Investigators Typically Process the Results
Apr 2013
Defining And Managing User Requirements For Computer System Validation
Mar 2013
Bioanalytical Methods Validation
Mar 2013
Raw Materials Risk Management in GMP Facilities: Avoiding GMP non-Compliance Due to Raw Material Issues
Mar 2013
Global Medical Device Reporting - A Comparison of Worldwide Regulations
Mar 2013
Forecasting Clinical Study Enrollment and its Budget Considerations
Mar 2013
21 CFR Part 11 Electronic Records: Electronic Signatures
Mar 2013
Multichannel and Mobile Strategy for Pharma
Mar 2013
Transferring a Medical OEM Molding and Assembly Operation to a Manufacturer With Validated Systems and Processes
Mar 2013
Electronic Records & Electronic Signatures; 21 CFR Part 11
Mar 2013
Seeking Evidence in Clinical Trials in Hemoglobinopathy
Mar 2013
Risk Assessment - Compliance Using Easy To Fill Out Documentation
Mar 2013
Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems
Mar 2013
Achieving Efficient Market Access in Latin America
Mar 2013
You have a Sterility Failure or Bioburden Excursion - Now What?
Mar 2013
Engineering Change Management for Pharmaceutical Capital Projects
Mar 2013
Implementation and Utilization of Standard Operating Procedures (SOPs) at the Clinical Research Site
Mar 2013
Why are we seeing more Independent Data Safety Monitoring (DMC) use in Clinical Research
Mar 2013
FDA`s 21 CFR 11 Add-On Inspections - Recent Updates
Feb 2013
Maximizing the Performance & ROI in Clinical trials: A Personalized Approach
Feb 2013
The Role of Social Media in Food and Drug Advertising and Regulatory Compliance Implications
Feb 2013
Medicaid Drug Rebate Program (MDRP): A Primer
Feb 2013
Clinical Study Enrollment Metrics and Their Financial Impacts
Feb 2013
Advanced Cell Culture & Fermentation - Process Development & Manufacture
Feb 2013
The Clinical Trial Study Protocol (Advanced)
Feb 2013
Outsourcing Management - Effective Contract Manufacturers, Supplier Evaluation, Approval and Monitoring
Feb 2013
The Caronia Court Decision and Off-Label Promotion
Feb 2013
Medical Device Quality Management Systems
Feb 2013
Statistics for Quality Control and Process Validation: How Many Replicates
Feb 2013
Statistics for Quality Control and Process Validation: Linear Regression and Standard Curves
Feb 2013
Marketing Compliance for Pharma Management
Feb 2013
Using Statistics to Determine Sample Size
Feb 2013
Root Cause Analysis
Feb 2013
Environmental Monitoring and Contamination Control Plan
Feb 2013
Adaptive Clinical Trials - Clinical Trials Version 2.0
Feb 2013
Making All Data Count: FDA Acceptance of non-US Clinical Trials
Feb 2013
Effectiveness Measures in CAPA and Risk Management Plans: Applying LSS for Quality Metrics
Feb 2013
Law Enforcement and Pain Management
Feb 2013
Effective CAPA related to Managing Human Error
Feb 2013
Best Practices in Responding to Form 483s
Feb 2013
Scientific Documentation: What Is It, How It Has to Be Evaluated, and How It Can Be Used?
Feb 2013
Investigator Initiated Trials - What Are We Doing to Ensure Human Subject Protection?
Feb 2013
Training on Current ICH GCP Guidelines
Feb 2013
From Six Sigma to Re-Inventing Quality
Feb 2013
Social Media: Using The Legal Guideposts to Create Social Media Success (for Healthcare/Lifescience Companies)
Feb 2013
GMP Analytical Laboratory Audits - Planning, Preparation, Execution, and Resolution
Feb 2013
Deviation Management System
Jan 2013
Basic Cell Culture & Fermentation - Process Development & Manufacture
Jan 2013
Objectionable Microorganisms in Medicinal Products - Aseptic Environment
Jan 2013
Implementing Risk-based Verification for Pharmaceutical Manufacturing Companies
Jan 2013
Optimal Clinical Supply Planning for Global Drug Development
Jan 2013
Essentials of Sterilizing Grade Filter Validation
Jan 2013
Pharma and Biopharma Quality System Refresher Course
Jan 2013
Sampling Plans for (FDA) Quality Audits
Jan 2013
Product Complaint Investigations - The application of Lean Six Sigma methodology for U.S. FDA-Regulated Industries
Jan 2013
Patient Reported Outcomes (PROs): Overview and Guidance for clinical trials and medical product labeling
Dec 2012
Reducing eDiscovery risk for Pharmaceutical Companies
Dec 2012
Cost-Effective Computer System Validation: Step-by-Step
Dec 2012
Responding to FDA 483`s
Dec 2012
Recalls & Vigilance - When to Report Complaints
Dec 2012
Quality Assurance at the (Clinical Research) Site: How to Develop a Manageable Plan
Dec 2012
Root Cause Analysis and Documentation Requirements for CAPA
Dec 2012
Change Control - Key to Successful cGMP Compliance
Dec 2012
Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner -Webinar By GlobalCompliancePanel
Dec 2012
21 CFR Part 11: Auditing for Part 11 Compliance
Dec 2012
Managing Your Medical Device Reporting (MDR)Program for Compliance Success
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Ensuring Integrity and Security of Electronic Records for FDA Compliance
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Product Hazard Analysis and Risk Management Under ISO 14971 and FDA, ICH Q9
Nov 2012
Practical strategies to Improve Productivity in the Pharmaceutical Laboratory
Nov 2012
Good Deviation Practice: what you need to know
Nov 2012
FDA Guidance Regarding Clinical Trials for Foods, Food Ingredients, and Dietary Supplements
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Obtaining an FDA Investigational Device Exemption - Webinar By GlobalCompliancePanel
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Configuration Management and Change Control for Computer Systems
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21 CFR Part 11 - Complete Manual for Compliance and Success
Nov 2012
Implementing Medical Device Complaint Handling Systems
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The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND: Comparing the Content and Agency Expectations
Nov 2012
Avoiding an FDA Warning Letter with a Strong CAPA Program
Nov 2012
Pharmaceutical Water System Sampling: Avoiding Problems by Doing It Right & The Practicality of Real-Time Release
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Aspects to Consider for Clean Room Qualification and Operation
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21 CFR Part 11: Complying with Part 11 Regulation - Understanding the Predicate Rule
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Introduction to Biotechnology Analytical Methods
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How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
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Computer Systems Used in Clinical Trials
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Laboratory Water Systems: Necessary Water Specifications and Validation Challenges
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Avoiding 483 Observations and Warning Letters
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21 CFR Part 11: Ins and Outs of Audit Trails
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Live webinar on Preclinical studies regulatory requirements and principle of Good Laboratory Practices (GLP)
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Developing and Maintaining Pre-marketing Master Regulatory Files
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Safety Critical Software - Software Risk Management
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Live webinar on Auditing Software Vendors & Service Providers for 21 CFR Part 11
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Clinical Trials Drug Supply: Imports and Release Procedures for Shipping to Trial Sites
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CDISC – Insight, Impact and Implementation
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Clinical Trial Billing - Building a Compliant Process that Works!
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Anticipated Changes to the EU Medical Device Directives; 2010 Changes and What the Future Holds for Licensees - Webinar By GlobalCompliancePanel
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Successful 510(k) submission: Contents and Format
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Update on Unique Device Identifier for Device Manufacturers
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FMEA and Risk Management for Medical Devices
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21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection
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Hazard Analysis – A practical guide
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Risk Assessment-Compliance Using Easy To Fill Out Documentation
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How to Select Best Practices a CRO ?
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Personalised Medicine: Overcoming Regulatory and Commercial Challenges
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Incorporating Six Sigma DMAIC into CAPA
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Creating Effective Master Validation Plans
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Investigator Initiated (Sponsored) Trials – ISSs
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Stability Studies for Vaccine Products
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Key Steps to Avoid 483 Warning Letters & Remediation if you get one
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Eliminate the Confusion – Analytical Method Qualification and Validation
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The Challenge of Multi-drug Resistant Organisms (MDROs) in LTCFs - Webinar By MentorHealth
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(QMS) Competence and Training Requirements per FDA QSR and ISO 13485
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Project Management for Computer Systems Validation - Webinar By GlobalCompliancePanel
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Key Concepts in Successful Water System Sanitization - Webinar By GlobalCompliancePanel
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Strategies for Preparing and Submitting Successful Citizen Petitions and Suitability Petitions to FDA
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Validation and Use of Excel Spreadsheets in Regulated Environments - Webinar By GlobalCompliancePanel
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Site Challenges in Conducting Investigational Device Trials
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Hospital Incident Command System (HICS) - Webinar By MentorHealth
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Management Controls Under QSR and ISO 13485 - Webinar By GlobalCompliancePanel
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FDA Guidelines on in Class in Man Compounds Targeting Tumor Bioenergetics from Lab Bench to Clinical Trials - Webinar By GlobalCompliancePanel
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Navigating the 510(k), IDE and PMA Submission and Approval Process - Webinar By GlobalCompliancePanel
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Addressing Impurities in Pharmaceutical Products: Impurities, Degradants, Residual Solvents and Elemental Impurities
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Pharmaceutical Filings & Registration Procedures in the EU - Webinar By GlobalCompliancePanel
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Medical Informatics: Managing for Efficiency and Efficiency - Webinar By MentorHealth
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Human Behavior in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel
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How to Survive a DEA Inspection Series: DEA Due Diligence for Manufacturers and Distributors by onlinecompliancepanel
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Changes to Good Pharmacovigilance Practices in the EU - Webinar By GlobalCompliancePanel
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Hazard Analysis vs. FMECA – Differences and Commonalities - Webinar By GlobalCompliancePanel
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CE Marking for Medical Devices Including In Vitro Diagnostic Devices - Webinar By GlobalCompliancePanel
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Common Problems with Software Validation Processes - Webinar By GlobalCompliancePanel
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Avoiding 483 Warning Letters & Remediation if you get one - Webinar By GlobalCompliancePanel
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Validating Excel and Word - Webinar By GlobalCompliancePanel
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GMP for Phase 1 Products - Webinar By GlobalCompliancePanel
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Implementing a Quality Systems-Based Approach to GCP Compliance - Webinar By GlobalCompliancePanel
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Sterilization as a Benchmark for Cleaning Validation and Control - Webinar By GlobalCompliancePanel
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FDA Guidance Regarding Software Validation for Clinical Trial Management Systems - Webinar By GlobalCompliancePanel
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Regulatory Complaint Handling, MDR`s & Recalls - Webinar By GlobalCompliancePanel
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Common Sense Water System Validation - Webinar By GlobalCompliancePanel
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The Use and Mis-use of FMEA in Medical Device Risk Management
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Ethics and Scientific Misconduct in Regulated Studies
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Complaint Handling and Management: From Receipt to Trending - Webinar By GlobalCompliancePanel
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Strategic Selection and Development of Immunogenicity Binding Methods
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Software validation and 21 CFR Part 11 remediation planning: FDA inspection strategies
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Software V&V Protocols and Documentation - Webinar By GlobalCompliancePanel
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Software Validation Planning for Executives and Managers - Webinar By GlobalCompliancePanel
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Auditing an Active Pharmaceutical Ingredient (API) Contract Manufacturing Organization (CMO) - Webinar By GlobalCompliancePanel
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Avoiding Statistical Pitfalls during Method Validation - Webinar By GlobalCompliancePanel
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Specialized Formulations – Biomolecules
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IEC 62304 for Medical Device Software Development: Steps to Compliance - Webinar By GlobalCompliancePanel
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How to Prepare for a Tag Along Audit of CFR 21 Part 11 - Webinar By GlobalCompliancePanel
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Cleanroom Management – From a Microbial Perspective
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What Every FDA Regulated Company Needs to Know About its FDA District Office
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TM’s world Protein & Enzyme online conference
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Navigating the Japan Regulatory and Clinical Trial Environment; Conducting Clinical Studies in Japan
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The Drug Development Process - From R&D to Commercialization - Webinar By GlobalCompliancePanel
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Clinical Trial Auditing - Identifying risks and building a more compliant and successful trial
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Integrating the Pharma Supply Chain According to FDA Expectations
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Risk Management for Medical Devices - Webinar By GlobalCompliancePanel
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Good Pharmacovigilance Practice - Inspection and Audits - Webinar By GlobalCompliancePanel
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How to Bullet Proof your Documents from Most Commonly Cited GDP Violations - Webinar By GlobalCompliancePanel
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FDA’s Regulation of Veterinary Regenerative Medicine
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Good Laboratory Practices for Bioanalytical Laboratories - Webinar By ComplianceOnline
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Recommendations for Cell Banks used in GXP testing - Webinar By ComplianceOnline
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Prepare for Tougher cGMP Compliance Audits - Webinar By GlobalCompliancePanel
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Process Validation - Webinar By ComplianceOnline
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The U.S. FDA`s New Global Engagement Initiative - Webinar By ComplianceOnline
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Understanding Costs of a Study for Clinical Trials - Webinar By ComplianceOnline
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REMS Update: Risk Evaluation and Mitigation Strategies - Webinar By ComplianceOnline
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Auditing Systems for 21 CFR Part 11 Compliance
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Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations: One and a Half-day In-person Seminar
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Medical Device Postmarketing Vigilance Reporting: Update and Expectations for Manufacturers - Webinar By GlobalCompliancePanel
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Residual Moisture Testing of Lyophilized Products - Webinar By GlobalCompliancePanel
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Practical Issues with Conducting Multi-National Clinical Trials for Medical Device Approval in the US
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Test Article Management and Characterization for Drugs and Devices - Webinar By ComplianceOnline
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Effective Corrective and Preventive Actions (CAPA): 10 Steps - Webinar By GlobalCompliancePanel
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Lean-Agile Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel
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Implementing Management Responsibility for Medical Devices - Webinar By GlobalCompliancePanel
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Unsolicited Drug and Device Off-Label Claims Via Social Media and Risk Management
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Leadership in Manufacturing Contamination Control - Webinar By GlobalCompliancePanel
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The 21 Elements of a 510(k) - Webinar By ComplianceOnline
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What Are the Current Tools and Best Techniques for (Clinical Trial) Audit/Inspection Preparedness?
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Preparing for FDA Inspection and Handling the Consequences
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Risk & Benefit Management in Drug Safety
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Making Sense of FDA’s (proposed) Rules for the Development and Approval of Biosimilars
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Pre-Approval Statements and Representations by Pharmaceutical Manufacturers
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Validation of Analytical Methods for FDA Compliance: Step-by-Step - Webinar By GlobalCompliancePanel
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An Overview of Risk Management and Risk Analysis Techniques in Clinical Trials
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Supplier Controls to Meet Tougher U.S. FDA Requirements
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Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel
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FDA Concerns on Alarm Standards and Safety
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Cosmetics – How Are they Regulated?
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Efficient Computer System Validation - 10 Easy Steps - Webinar By GlobalCompliancePanel
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Equipment Calibration in FDA QSR – Regulations and Warning Letters
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Statistics in Pharmaceutical Quality Control
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Integrating Clinical Evaluation and Risk Management
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Market and Patient Access for Chronic Disease Therapies
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Pre-Formulation and Formulation Development of a Sound Bio Pharmaceutical Formulation that is cGMP Compliant
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Device Changes and the 510(k) - Webinar By GlobalCompliancePanel
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Establishing and following Good Clinical Practice (GCP) compliant with the FDA requirements
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Dietary Supplement Regulatory Compliance in the United States: Labeling, Product Claims & Updates from the FDA
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Effective Root Cause Analysis and CAPA Program
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How to prepare for 510(k)s for in vitro diagnostic devices (IVDs)
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Medical Device Process Validation - Statistical Aspects - Webinar By GlobalCompliancePanel
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Applying GMP Quality Principles To Establish A Reduced Testing Program
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South Korea: Navigating the Clinical Trial and Regulatory Environment - Webinar By GlobalCompliancePanel
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Physician Payment Sunshine Act and State Sunshine Law Compliance. Are you Prepared for the New Federal Requirements and Existing State Requirements?
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How to Survive FDA`s `New` Inspection and Enforcement Practices
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The Hero of Manufacturing Contamination Control - The Microbiology Lab
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DEA, Your Registration and How to Lose It
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TM’s world Virology & Microbiology online conference
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Applying Quality and Process Excellence in Pharma
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Acceptance Activities in FDA QSR - Regulations and Warning Letters
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Issue Detection and Escalation in Clinical Trial Settings
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Validation and Use of Excel Spreadsheets in Regulated Environments
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Quality Agreements with Pharmaceutical/ Biologic Manufacturers and the Use of Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities
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Foreign Manufacturing Facilities – Avoiding Problems with FDA
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Best Practices for Maintaining an IND and IDE Application with FDA
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Master Verification & Validation Planning under U.S. FDA CGMP, ICH Q-series and ISO 13485-14971 Requirements - Webinar By GlobalCompliancePanel
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Regulatory Barriers for the Implementation of Pharmacogenomics for Personalized Medicine
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How To Establish An Effective Good Clinical Practice in Drugs and Medical Devices
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Live webinar on Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina) By Compliance2go
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Understanding Disinfection and Cleanroom Cleaning in a FDA Regulated Environment
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Doing Business Despite Embargoes and Sanctions: OFAC Licensing
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Business Process Optimization in Pharmacovigilance - Webinar By GlobalCompliancePanel
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Implementing the New USP Chapter <1224> for Analytical Method Transfer
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Validation of Bioanalytical Methods and Procedures for FDA Compliance
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Auditing Computer Systems for FDA and International Compliance - Webinar By GlobalCompliancePanel
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FDA`s Rules for Financial Disclosure in Clinical Trials Clarified: New Guidance, Practical Application
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Managing Immunogenicity Risk in Biopharmaceuticals
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How to Develop, Monitor and Effectively Communicate your Risk Control Strategy - Webinar By GlobalCompliancePanel
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Webinar: When Do You Need a 510K?
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Method Validation in Drug Development Process - Common Mistakes and Issues
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Audit/Inspection Preparedness for Clinical Research/Site Coordinators
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Software Verification and Validation Planning and Implementation
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Changes to Medical Records: How to manage changes and meet regulatory requirements
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Validation of Analytical Procedures for Use in the Pharmaceutical Industry
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Submission Documentation for Sterilization Process Validation - A Comprehensive View of Content for an Approvable CMC Section
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Implement a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel
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Dietary Supplement Regulatory Compliance in the United States: Labeling, Product Claims & Updates from the FDA - Webinar By GlobalCompliancePanel
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Quality System Approach and Risk Management for Clinical Trials
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FDA/EU Compliant Training for Laboratory Personnel
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FDA’s Current Thinking for Industry cGMPs for Phase 1 INDs
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Does your pharmaceutical lab have GMP and non-GMP functions?
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Product Risk Management Under ISO 14971 and FDA-ICH Q9 - Webinar By GlobalCompliancePanel
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Annual Best Practice Phase IV studies
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Solutions for Addressing Fungal and Bacterial Spore Outbreaks in Pharmaceutical, Biotech, and Medical Device Operations
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Risk Analysis for Portfolio of Drug Development Programs - Webinar By GlobalCompliancePanel
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Preparing for FDA GCP Inspections – Essentials for Sponsor Companies
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The Evolving State of U.S. Sanctions Against Iran
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Introduction to the Electronic Common Technical Document
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Analytical Procedures and Procedures Transfer
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Validation and use of Access Databases in FDA regulated environments
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Quality by Design (QbD) for Development and Validation of Analytical Methods
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Annual Oncology Market & Patient Access
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New Dietary Ingredients in the Regulatory Scheme
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Troubleshooting Microbial Excursions in Pharmaceutical and Biotech Operations
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SOPs for Clinical Trials – Regulatory Requirement and Key to Effective Management
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Purposeful Water and Steam System Validation – Not Just A Regulatory Requirement
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An Introduction to the FDA New Drug Approval Process
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How to Format Succinct and Comprehensive 510(k)s and PMAs
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Introduction to FDA Good Documentation Practices
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Major CGMP Issues for
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Live Web Seminar China: Compliance Processes for Life Science Products (Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations By compliance2go
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FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality Control
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Proven Root Cause Investigation Techniques for Pharmaceutical Water Systems
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Pharmaceutical and Medical Device Good Manufacturing Practices - Similarities and Differences - Webinar By GlobalCompliancePanel
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Lyophilization Process Development and Cycle Design
Nov 2011
Live webinar on New Changes to HIPAA Rules - Their expected impact and enforcement schedule By Compliance2go
Nov 2011
Live webinar on GMP Quality Principles Embodied in the FDA`s Quality Systems Approach to the Pharmaceutical GMP`s and ICH Q 10, Pharmaceutical Quality Systems by Compliance2go
Nov 2011
Key Aspects of the Trial Master File and How to Pass FDA Inspection - Webinar By GlobalCompliancePanel
Nov 2011
Document Approval, Control, and Distribution: How to Develop a Compliant, Cost Effective System By Compliance2go
Nov 2011
Best Practices in Complaint Management - Webinar by GlobalCompliancePanel
Nov 2011
Equipment Validation, Tracking, Calibration, and Preventive Maintenance - Webinar By GlobalCompliancePanel
Oct 2011
Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel
Oct 2011
Live webianr on Basic and Advanced Quality Tools: What every quality professional is expected to know by compliance2go
Oct 2011
Live webinar on The FDA Inspection: Preparation, Performance, and Follow-up by compliance2go
Oct 2011
Live webinar on New 21 CFR Part 11 Regulations and How to comply with them by Compliance2go
Oct 2011
Live webinar on HIPAA and EHRs - what your systems need to do so you can be in compliance with new rules by compliance2go
Oct 2011
FDA`s Draft Guidance on Financial Disclosure by Clinical Investigators - Webinar By GlobalCompliancePanel
Oct 2011
Introduction to Contamination Control Master Plans - Webinar by GlobalCompliancePanel
Oct 2011
Effective Internal Auditing-Making Quality Systems More Efficient for the Medical Products Industry - Webinar By GlobalCompliancePanel
Oct 2011
IT Infrastructure and Network Qualification: Step-by-Step
Oct 2011
Risk Management during device design according to ISO14971 - Webinar By GlobalCompliancePanel
Oct 2011
Meeting Annual U.S. FDA cGMP Training Requirements - Webinar By GlobalCompliancePanel
Oct 2011
The Drug Development Path - From R&D to Commercialization - Webinar by GlobalCompliancePanel
Oct 2011
Hybrid Quality Systems For Pharmaceuticals - Combining ICH Q7A & Part 210-211 - Webinar By GlobalCompliancePanel
Sep 2011
Good Laboratory Practice Regulations: Introduction and Strategies for Implementation
Sep 2011
FDA Validation Requirements - Webinar By ComplianceOnline
Sep 2011
Drug Master Files - Understanding and Meeting your Global Regulatory and Processing Responsibilities
Sep 2011
Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities By compliance2go
Sep 2011
Investigator responsibilities and Legal commitments in Drug and Device Clinical Research
Sep 2011
Applying GMP Quality Principles to Deviations & Nonconformities and Effective Corrective And Preventive Action Systems-By Howard T. Cooper
Sep 2011
Applying GMP Quality Principles to Deviations & Nonconformities and Effective Corrective And Preventive Action Systems
Sep 2011
How to design A CAPA System that meets Compliance Requirements
Sep 2011
Ensuring Integrity and Security of Laboratory Data
Sep 2011
Responding to FDA Form 483s and Warning Letters - Webinar By ComplianceOnline
Sep 2011
Master Validation Planning
Aug 2011
Common GCP Violations and Site Mistakes - How to Avoid them
Aug 2011
Global HTA and CER Forum
Aug 2011
Stability Testing Training Online
Aug 2011
Effective Hazard Analysis to meet FDA and ISO13485:2003 Risk Management Requirements
Aug 2011
Design, Planning and Conducting Effective Audits
Aug 2011
Preparing for an FDA Pre-Approval Inspection - Webinar By ComplianceOnline
Aug 2011
Design History File (DHF) Device Master Record (DMR) Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained
Aug 2011
A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11, Electronic Records, Signatures
Aug 2011
Why Post-market Pharmacovigilance trials are increasingly seen : What do they tell us and why are they important
Aug 2011
Design Reviews for Efficiency and Efficacy - Webinar By ComplianceOnline
Aug 2011
How Due Diligence in Accurate Adverse Event Reporting is the Key to a clean FDA Audit
Aug 2011
Understanding the Difference: HIPAA Security Compliance Assessment v. HIPAA Security Risk Analysis
Aug 2011
How to Survive a DEA Inspection Series: Only Manufacturers and Distributors
Aug 2011
How to write Standard Operating Procedures (SOPS) & Work Instructions (Wis) that Meet and Exceed Compliance Requirements
Aug 2011
Social Media in Pharma Summit
Aug 2011
Clinical Project Management - Webinar By ComplianceOnline
Aug 2011
The latest FDA and EMA hot area for citations, warning letters and other actions
Aug 2011
Creation and management of a Controlled Document System for a Life Sciences manufacturing plant utilizing the principles of Lean Documents and Lean Configuration
Aug 2011
Vendor Qualification - Designing and Implementing an Efficient and Compliant Vendor Program
Aug 2011
FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes - Webinar by GlobalCompliancePanel
Aug 2011
Trial Master File for Research Sites: Can You Pass FDA Inspection?
Aug 2011
Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11
Jul 2011
Full day Virtual Seminar on Pharmaceutical Stability - Webinar By ComplianceOnline
Jul 2011
Clinical Document Management and Collaborative Electronic Data Exchange in Clinical Trials
Jul 2011
Vendor Qualification Auditing for FDA Computer System Compliance - Webinar By ComplianceOnline
Jul 2011
Advertising and Promoting FDA Regulated Products - Webinar By ComplianceOnline
Jul 2011
The Investigational Medicinal Product Dossier (IMPD): EU`s CTA vs. FDA`s IND
Jul 2011
Full-day Virtual Seminar: IND Applications for the US FDA
Jul 2011
Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements
Jul 2011
Using the USP Effectively - Webinar By ComplianceOnline
Jul 2011
How to Meet HIPAA-HITECH Encryption Requirements - Webinar By ComplianceOnline
Jul 2011
Validation of Analytical Methods and Procedures - Webinar By ComplianceOnline
Jul 2011
Eliminate the Confusion - Compliance for Anesthesia Services
Jul 2011
DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel
Jun 2011
Navigating the new FDA world of Combination Products
Jun 2011
Designing an effective cleaning validation in today`s regulatory environment
Jun 2011
How to Survive a DEA Audit - Webinar By GlobalCompliancePanel
Jun 2011
Understanding good Closed Loop CAPA system - Webinar By GlobalCompliancePanel
Jun 2011
Effective Risk Based Approach to Auditing and Qualifying Suppliers and Vendors - Webinar By GlobalCompliancePanel
Jun 2011
Risk-Based Validation for GxP Facilities - Webinar By GlobalCompliancePanel
Jun 2011
Good Documentation Practices for Laboratory Operations - Webinar By GlobalCompliancePanel
Jun 2011
Patient Recruitment & Retention – Challenges & Best Practices
May 2011
`The Right Stuff` – Implementing Quality Control Tools in Quality Systems Operations
May 2011
Sterilization Options for Challenging Products
May 2011
Pharmaceutical and Medical Device Validation Guidance`s - Similarities and Differences - Webinar By GlobalCompliancePanel
May 2011
Information Security and Payment Card Rules: Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliancePanel
May 2011
Test Method Validation - The Characteristics- Webinar By GlobalCompliancePanel
May 2011
Retirement of Computer Systems: Strategies for FDA Compliance and Tools for Implementation
May 2011
The GCP/ICH Obligations of Sponsors, Monitors, and Investigators - barriers and solution - Webinar By GlobalCompliancePanel
May 2011
FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP
May 2011
Residual Moisture Testing - Proven Techniques
May 2011
Information Security Risk Analysis: Meeting HIPAA Requirements and the Meaningful Use Objective - Webinar By GlobalCompliancePanel
May 2011
FDA`s New Enforcement of 21 CFR Part 11 - Webinar By GlobalCompliancePanel
May 2011
Gowning Systems Used in Cleanrooms & Controlled Environments - Webinar By GlobalCompliancePanel
Apr 2011
Avoiding `Failure to Investigate` - Observations by Conducting Effective Investigations
Apr 2011
Develop appropriate validation activities to meet U.S. FDA, ICH Q9 and ISO 14971
Apr 2011
Establishing a Reduced Testing Program for Pharmaceutical & Medical Device Components
Apr 2011
Best Practices for the Implementation and Use of Test Management Tools - Webinar By GlobalCompliancePanel
Apr 2011
How to successfully create a Device History Record and keep FDA happy in the process - Webinar By GlobalCompliancePanel
Apr 2011
The 510(k) Process and Risk Management
Apr 2011
Salmonella: Evolution, Epidemiology, Detection and Control
Apr 2011
FDA`s Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List - Webinar By GlobalCompliancePanel
Apr 2011
Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP
Apr 2011
Data Security Analysis for Healthcare Providers - Webinar By GlobalCompliancePanel
Apr 2011
Elements of the Lot Disposition Process - Webinar By GlobalCompliancePanel
Apr 2011
ComplianceOnline Webinar - Why and How - Verification of Compendial Methods - USP [1226]
Apr 2011
FDA`s Revised 510(k) Premarket Notification Process
Apr 2011
Understanding ISO 22000:2005
Apr 2011
Vendor/Supplier/CRO Compliance – Lessons Learned & Rules to Live By
Apr 2011
A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences - Webinar By GCPanel
Mar 2011
The Pharmaceutical Quality System - Webinar By GlobalCompliancePanel
Mar 2011
Navigating the Regulatory Environment for the Implementation of Alternative Microbiology Technologies - Webinar By GCPanel
Mar 2011
Disinfectant Validation and Cleanroom Cleaning for all FDA and EMEA regulated companies
Mar 2011
A Comparison of ICH Q-10 Quality System and the FDA’s Quality Systems Approach (QSA) to the Pharmaceutical cGMPs
Mar 2011
How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant?
Mar 2011
Process Validation: current industry practices and FDA Guidance Document Review - Webinar by GlobalCompliancePanel
Mar 2011
Manufacturing Process Validation
Mar 2011
The Investigation System (Discovery, Planning, Root Cause Analysis, CAPA) - Webinar By GlobalCompliancePanel
Mar 2011
Why is CAPA so often cited in medical device inspections - Webinar By GlobalCompliancePanel
Feb 2011
How to secure GCP compliance in Clinical Trials: The complete overview of the critical parameters 2010
Feb 2011
Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel
Feb 2011
Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel
Feb 2011
Software Verification and Validation Planning and Execution
Feb 2011
21 CFR Part 11: Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel
Feb 2011
Electronic Raw Data in Regulated Environments - Definition, Recording and Archiving - Webinar By GobalCompliancePanel
Feb 2011
Eliminate the Confusion –Annex 13 GMP guide
Feb 2011
Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel
Feb 2011
Controlled Substances and the Pharmacist - Webinar By GlobalCompliancePanel
Feb 2011
21 CFR Part 212: Quality Systems to Ensure cGMP Compliance
Feb 2011
Full Day Virtual Seminar : Annual GLP Refresher Course
Feb 2011
Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By GlobalCompliancePanel
Feb 2011
Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel
Feb 2011
Analytical Instrument and Equipment Qualification in Quality Laboratories - Webinar By GlobalCompliancePanel
Feb 2011
Risk-Based Verification and Validation Planning to Meet U.S. FDA, ICH Q9 and ISO 14971
Feb 2011
Understanding and Implementing FDA’S 21 CFR Part 11
Feb 2011
How to transfer QC procedures for commercial products in pharma industry - ICH and USP guidelines
Feb 2011
Design Validation Protocol and Acceptance Criteria for Chromatographic Methods to meet ICH requirements 2010
Jan 2011
Medical Device Complaints Handling Strategies for Managing Your Biggest Compliance Challenge
Jan 2011
Ethics, Standards and Identifying Risks in Clinical Research - ComplianceOnline Clinical Training
Jan 2011
Webinar on Pharmacovigilance Audit - Webinar By GlobalCompliancePanel
Jan 2011
Full Day Virtual Seminar - Understanding Biofilm and Controlling It in Pharmaceutical Water Systems
Jan 2011
Full day Virtual Seminar - Compliance for 21 CFR Part 11, reducing costs using risk-based computer system validation
Jan 2011
Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel
Jan 2011
Defining and Managing Protocol Deviation/Violation/Exception - Webinar By GlobalCompliancePanel
Jan 2011
Anatomy of a Medical Device Inspection: From EIR to 483 to Warning Letter
Jan 2011
Understanding and Preparing for FDA`s New Part 11 Inspection Program - Webinar By GlobalCompliancePanel
Jan 2011
cGMP: Strategies for implementation and compliance for Phase I Investigational Drug and Biologic products
Jan 2011
Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel
Jan 2011
Internal 21CFR Part 11 Compliance Auditing of Computer Systems - Webinar By GlobalCompliancePanel
Jan 2011
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompliancePanel
Jan 2011
Statistical Sampling Plans for Audits - Webinar By GlobalCompliancePanel
Jan 2011
Establishing Global Drug Substance and Drug Product Specifications – What the Guidelines Don’t Tell You
Jan 2011
101 cGMP To-Do List for - Webinar By GlobalCompliancePanel
Jan 2011
Navigating Pediatric Trials from recruitment to successful on-time completion - Webinar By GlobalCompliancePanel
Jan 2011
Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities - ComplianceOnline Pharmaceutical Training
Jan 2011
A Comparison of ICH Q-10 Quality System and the FDA`s Quality Systems Approach (QSA) to the Pharmaceutical GMPs - Webinar By GlobalCompliancePanel
Jan 2011
Solutions for addressing microbial excursions in medical device, pharmaceutical, and biotech industries
Jan 2011
What are the Scientific Basis of Clinical Research and the hall mark of a good study protocol?
Jan 2011
How to Set up Data Monitoring Committees (DMCs / DSMBs) and what is effect on the Drug Development Process - ComplianceOnline Clinical Training
Dec 2010
Practical Strategies to a successful 505(b)(2) product - ComplianceOnline Pharmaceutical Training
Dec 2010
The FDA`s Working Group Reports, I & II - New Directions - Webinar By GlobalCompliancePanel
Dec 2010
Validating Excel and Word Applications Documents - ComplianceOnline Medical Device Training
Dec 2010
Assessing GCP Compliance in Clinical Trial Audits- Risk management and Best practices - ComplianceOnline Clinical Training
Dec 2010
Important requirements when validating sterilizing grade filters - ComplianceOnline Biotechnology Training
Dec 2010
Basics of OTC Drug Labeling Compliance - Webinar By GlobalCompliancePanel
Dec 2010
Know Your Customer - The DEA Due Diligence - Webinar By GlobalCompliancePanel Conference
Nov 2010
Conducting Clinical Trials in Latin America: keys to successful study implementation
Nov 2010
Best Practices of Recruiting Subjects in Conducting Clinical Trials: What does it take to be successful - ComplianceOnline Clinical Training
Nov 2010
How to Use Foreign Trial Data in Your NDA Approval Process
Nov 2010
Full Day Virtual Seminar - Reduce Software Validation Costs and Pass the New 21 CFR Part 11 Inspections - by GlobalCompliancePanel
Nov 2010
Meeting the FDA: How to get the best advice from the FDA - ComplianceOnline FDA Training
Nov 2010
Weight Management
Nov 2010
Controlling Change to meet GMP Requirements
Nov 2010
Clinical Trial Regulations and GCP Compliance as they relate to Adverse Events - How to Assess and report AEs and SAEs
Oct 2010
Quality System Regulation (QSR) Management Responsibilities
Oct 2010
FDA`s Update on Medical Device Labeling Changes - Webinar by GlobalCompliancePanel
Oct 2010
ICH Q7 Guidelines and Practical Approaches to Manufacturing APIs - Webinar by GlobalCompliancePanel
Oct 2010
The Most Common Problems in FDA Software Validation & Verification - Webinar by GlobalCompliancePanel
Oct 2010
Drug Safety Assessment and Risk Minimization in the Development Period
Oct 2010
Full Day Virtual Seminar - Design and Validation of Excel Spreadsheets: Step-by-Step
Oct 2010
Navigating Pediatric Trials from recruitment to successful on-time completion
Oct 2010
ComplianceOnline Virtual Seminar - 21 Cfr Part 11: Complete Manual For Compliance Success
Oct 2010
Validation Basics A-Z: Planning, Implementing & Maintaining
Oct 2010
Medical Device Classification - Webinar by GlobalCompliancePanel
Oct 2010
The ICF Process: Tips on Achieving Optimal compliance and Comprehension - Webinar by GlobalCompliancePanel
Oct 2010
Using Social Media in a FDA Compliant Manner
Oct 2010
European Drug Safety and Pharmacovigilance Compliance - Webinar by GlobalCompliancePanel
Oct 2010
Master Verification and Validation Planning to Meet US FDA, ISO 13485 and 14971:2009 Requirements - Webinar by GlobalCompliancePanel
Oct 2010
The Tougher U.S. FDA - One Year Later
Oct 2010
ComplianceOnline Webinar - Preparing for and handling FDA Laboratory GMP inspections
Oct 2010
Regulatory Complaint Handling, MDR`s & Recalls - Webinar by GlobalCompliancePanel
Oct 2010
Data Monitoring Committees (DMCs) effect on subject safety in clinical research and how to set it up to be effective
Oct 2010
Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner - Webinar by GlobalCompliancePanel
Oct 2010
What exactly is required for 21 CFR Part 11 compliance?
Oct 2010
Secrets of an Effective CMC Regulatory Strategy for Biopharmaceuticals Part 1 - Cell Banking - Webinar by GlobalCompliancePanel
Oct 2010
Best Practices for Writing an Effective SOP to Lead to Successful FDA Inspections
Oct 2010
Integrating Clinical Evaluation and Risk Management (ISO 14971)
Oct 2010
The FDA Tripod - Clinical Trial Regulations, Compliance and GCP in Drug Development
Oct 2010
Signal Detection and Case Processing: Business Process Optimization in Pharmacovigilance - Webinar by GlobalCompliancePanel
Oct 2010
ComplianceOnline Webinar - GMPs in Biopharmaceutical Development Laboratories
Oct 2010
How to Survive a DEA Audit or FIND=FINE - Webinar by GlobalCompliancePanel
Sep 2010
Best Practices for Managing FDA Investigators and Handling FDA 483 Observations
Sep 2010
Development, Management, and Operation of an Effective Supplier and Internal Auditing System - Webinar by GlobalCompliancePanel
Sep 2010
Ensuring GCP compliance through quality auditing in clinical trial
Sep 2010
The FDA Tripod - Clinical Trial Regulations, Compliance and GCP in Drug Development - Webinar by GlobalCompliancePanel
Sep 2010
Preparing for and Surviving an FDA Inspection - Webinar by GlobalCompliancePanel
Sep 2010
Understanding and Preparing for FDA`s New Part 11 Inspection Program
Sep 2010
CAPA for Manufacturing, Financial Service Companies: Get it Right the Time (Efficient Process)
Sep 2010
Compiling the Design History File, and Technical File / Design Dossier - Webinar by GlobalCompliancePanel
Sep 2010
Preparing for FDA Inspections in a Changing Regulatory Environment - Webinar by GlobalCompliancePanel
Sep 2010
The Cosmetic-Cosmeceutical Distinction: Walking the Line in Developing Label Claims - Webinar by GlobalCompliancePanel
Sep 2010
The ICF Process: Tips on Achieving Optimal compliance and Comprehension
Sep 2010
EU IMPD vs. US IND: Comparing the Content and Agency Expectations
Sep 2010
What are the “Good Clinical Practices” (GCP) of Research involving Human Subjects
Sep 2010
ComplianceOnline Webinar - Medical Device Changes and The 510(k)
Sep 2010
Developing Supplier Quality Auditor Training Programs
Sep 2010
Troubleshooting ethylene oxide (EO) processes - Webinar by GlobalCompliancePanel
Sep 2010
Risk Assessments - Key to a Viral Safety Management Plan
Sep 2010
Physical Properties Analytical and Screening Techniques - Webinar by GlobalCompliancePanel
Sep 2010
Understanding Acceptance Activities for Medical Devices - Webinar by GlobalCompliancePanel
Sep 2010
The role of Analytical Program to Support Drug Development Process
Sep 2010
Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 - Prepare Yourself for the upcoming FDA Part 11 Inspections - Webinar by GlobalCompliancePanel
Sep 2010
Signal Detection and Data Mining - Webinar by GlobalCompliancePanel
Sep 2010
Key Factors to Write an Effective Standard Operating Procedure (SOP)
Sep 2010
Engineering and Laboratory Mythology with Water System
Sep 2010
Effective & Essential CAPA process to avoid FDA 483 - Webinar by GlobalCompliancePanel
Sep 2010
Key Modules of an Effective CAPA SOP - Webinar by GlobalCompliancePanel
Sep 2010
Understanding Corrective and Preventive Action, and Elements of a CAPA System - Webinar by GlobalCompliancePanel
Sep 2010
Good Documentation Practices for GMP Operations - Webinar by GlobalCompliancePanel
Sep 2010
Conducting Value Added Audits of Technical Service Providers - Webinar by GlobalCompliancepanel
Aug 2010
ComplianceOnline Webinar - Streamline Documentation System in Pharmaceutical Laboratory
Aug 2010
Changes to the EU Variation Rules, Classifications and Submittal Requirements
Aug 2010
Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a Relatively Paper-Free Manner
Aug 2010
Process Validation for Drugs and Biologics
Aug 2010
Webinar on Pharmacovigilance Audit - by GlobalCompliancepanel
Aug 2010
Pharmaceutical Manufacturing Batch Record Review -Webinar by GlobalCompliancePanel
Aug 2010
Auditing a Process-based System - Webinar by GlobalCompliancePanel
Aug 2010

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