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Pharma Conferences (past events)

ComplianceOnline organizes international conferences, seminars, workshops and other events in various fields, including business, education, government, global issues, health, medicine, industry, lifestyle and science....

ComplianceOnline has a presence in more than 20 countries around the world, including, Australia, Austria, Bangladesh, Brazil, China, Ireland and Kuwait.

ComplianceOnline hosts events on a wide range of topics, such as Aerospace, Agriculture, Alternative medicine, Anaesthesiology, Architecture, Interior design, Artificial Intelligence (AI) and Banking, among others. The events are designed to provide a platform for professionals and others to exchange knowledge, network, discuss new developments in respective fields as well as showcase products and services to a targeted audience.

Related topics
Showing 513 conferences
Audits - Self/Internal, Vendor and Regulatory Inspections
Nov 2024
Statistical Elements of Implementing ICH Quality Guidelines
Mar 2023
The Veterinary Drug Approval Process and FDA Regulatory Oversight
Feb 2023
Latin America - Understanding Regulatory Compliance Requirements Across the Life Science Industry (Pharmaceuticals, Biologics, Medical Devices, IVDs)
Dec 2022
Change Control Best Practices - Avoiding Unintended Consequences of Changes
Jul 2022
Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices
Nov 2021
Data Integrity: FDA/EU Requirements and Implementation
Sep 2021
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
Mar 2021
FDA`s GMP Expectations for Phase IV and -in-Man Clinical Trials
Dec 2020
The A to Z`s of Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals, Biologics, Medical Devices, Cosmetics, and Personal Care Products
Sep 2020
FDA Audit, Quality Assurance Practices, Responsibilities and Expectations
Sep 2020
Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings
Jun 2020
Technical Writing for Pharma, Biotech and Med Devices
Jun 2020
Pharmaceutical Quality Management System (GMP Requirements, ICH Guidance, QbD, and USFDA/EMA Regulations)
Apr 2020
FDA`s New Import Program for - Strict Precision
Mar 2020
Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
Mar 2020
Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries)
Feb 2020
You have a BI Positive or Product Sterility Positive - Now What
Nov 2019
Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)
Nov 2019
Managing Your FDA Inspection: Before, During and After
Nov 2019
Designing and Sustaining New and Existing Product Stability Testing Program
Sep 2019
CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE
Sep 2019
Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines
Sep 2019
Identify and Manage Data Integrity Issues, CSV and 21 CFR Part 11
Sep 2019
Clinical Data Management (FDA E6 GCP Guidelines)
Aug 2019
Aseptic Processing Overview and Validation
Jul 2019
Process Validation - Overview of Why and How
Jul 2019
Packaging and Labeling in Pharmaceutical Production
Jul 2019
PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation
Jul 2019
6 Most Common Problems in FDA Software Validation and Verification
Jul 2019
Drug Master Files (DMF) - Translating FDA Guidances into usable documentation
Jul 2019
Basics of Testing Associated with Sterilization Validation and Routine Processing
Jul 2019
Scale-Up, Cycle Transfer, and Maximum Throughput Capability for Lyophilized Products
Jul 2019
Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters
Jul 2019
Effectively Addressing and Remediating FDA`s Form 483 Findings, Warning Letters and Consent Decree Compliance Issues
Jun 2019
Pharmaceutical Compressed Air – Quality GMP Standards and Requirements
Jun 2019
Supplier and Service Provider Controls: FDA Expectations
May 2019
New Elemental Impurities Tests for Pharmaceutical Products According to the New ICH Q3D and USP 232/233 Guidelines
May 2019
ICH Q7 FDA Guidance - Its Structure, History, Application and Writer`s Intent
May 2019
Documentation of Medical Necessity - Focus for OIG and other auditors
May 2019
Latin America – Understanding Regulatory Compliance Requirements Across the Life Science Industry
May 2019
FDA Recalls - Before You Start, and After You Finish
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
Compliance Measures for Case Managers
May 2019
Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities
Apr 2019
Practical Implementation of Pharmaceutical Quality Risk Management (QRM)
Apr 2019
Method Development and Validation for Assays Supporting Testing of Biologics
Mar 2019
QbD Approach to Analytical Method Lifecycle: Design, Development, Validation and Transfer
Mar 2019
How to Implement a Quality Management System According ISO 13485?
Mar 2019
How to apply ISO 62304 standard in a medical software development project?
Mar 2019
The Most Serious FDA 483s - How to Avoid Them
Mar 2019
CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers
Mar 2019
505(b)(2) NDAs
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
Validation and Use of Excel Spreadsheets in FDA Regulated Environments
Feb 2019
Compliance Risk Management in Medical Devices, Pharmaceuticals, and Combination Products
Feb 2019
Interdisciplinary Care Rounds: A Key Strategy for Improving Case Management Outcomes
Feb 2019
Tips and Techniques for Handling Missing Data (Statistical Techniques)
Jan 2019
How to Prepare for an FDA Inspections?
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
Verification vs. Validation in Regulated Industries
Jan 2019
Validation and Use of Cloud Computing in FDA Regulated Environments
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
Meet the Tougher U.S. FDA CGMPs
Nov 2018
Ensuring Integrity and Security of Laboratory Data
Nov 2018
Troubleshooting Ethylene Oxide (EO) Processes
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 controlled Raw Materials
Sep 2018
Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations (Updated to address recent Homeopathic Drug announcements by FDA & FTC)
Aug 2018
Marketing to Medicare or Medicaid Beneficiaries - What You Can and Cannot Do
Aug 2018
The Regulatory Expectations for Environmental Monitoring Programs
Aug 2018
Statistical Analysis for Product Development
Jul 2018
CMS Hospital CoP and TJC Telemedicine Standards, Telemedicine Credentialing and Privileging
Jul 2018
Laboratory Investigations for Out of Specification Results
Jul 2018
Opioid Abuse in the Workplace: Using Effective Drug Testing and Policies to Reduce the Pain of the Painkiller Epidemic
Jul 2018
Sunshine Act Reporting: Clarification for Clinical Research
Jul 2018
Good Documentation Guideline (Chapter <1029> USP)
Jul 2018
Root Cause Analysis (RCA) in the Laboratory - Addressing Non-Conformances
Jul 2018
Forced Degradation Studies/ Biologics Stability Programs for Biopharmaceuticals
Jul 2018
CMS New Requirements of Participation - Phase 2 : Do you know what is required?
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
Product Information for Medicinal Products in the EU
Jun 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
Why and How - Verification of Compendial Methods - USP [1226]
May 2018
Good Pharmacovigilance Practices in day-to-day Pharmacovigilance
May 2018
Gaining and Re-Establishing Control of Your Cleanroom
May 2018
Document Control and Change Control Process in GxP/GMP Environment
May 2018
Health Product Marketing authorization in Brazil - Documentation, Approval Process, Labeling, Advertising and Post Market Vigilance
May 2018
GMP Compliance for Quality Control and Contract Laboratories
Nov 2017
The Regulations of OTC Drugs
Oct 2017
Lifecycle Approach to Analytical Methods for Drug Products: Incorporating QbD Concepts into Method Development, Validation, Verification and Transfer
Oct 2017
Computer System Validation - Reduce Costs and Avoid 483s
Oct 2017
Pharmaceutical Quality Management System (GMP Requirements, ICH Guidance, QbD, and USFDA/EMA Regulations)
Oct 2017
FDA`s Import Program for - New Pathways and Pitfalls
Sep 2017
FDA`s Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies
Jul 2017
FDA Requirements for the Pharmaceutical Industry: Inspection, OTC Drugs, IND/NDA/ANDA, eCTD and GMP Requirements
Jun 2017
Bioanalytical Methods and Good Laboratory Practices (GLP) - Essential Elements for Pre-Clinical Studies during development of Drugs
Jun 2017
Auditing for Medical Device and Pharma Companies – A Tool to Reduce Quality and Compliance Risk
May 2017
Radiation Sterilization of Medical Products - Beyond the Basics
May 2017
US GCP Fundamentals for Pharmaceutical and Biologic Companies
May 2017
Data Integrity: FDA/EMA/TGA Requirements and Implementation
May 2017
CGMP Quality Principles for the FDA Regulated Industries: 2-Day In-Person Seminar
Nov 2016
How to Write Error Free Procedures and Instructions
Oct 2016
Why is FDA at my facility, and what do I do during an inspection?
Oct 2016
Analytical Methods in Development and Manufacture of Drugs and Biologics
Oct 2016
Advertising and Promotion of Dietary Supplements
Oct 2016
FDA`s Regulation of Implantable and Wearable Sensors
Oct 2016
Pharma Summit – Risk Control & Compliance
Oct 2016
How to Perform a Cognitive Load Assessment for Human Error Reduction
Sep 2016
Validation and Part 11 Compliance of Computer Systems and Data
Sep 2016
Regulatory Requirements and Principles for Cleaning Validation
Sep 2016
The Benefit/Risk Ratio: Pharmacovigilance, Medical And Regulatory Converge
Sep 2016
Understanding the Statistical Considerations for Quantitative ICH Guidelines
Aug 2016
Common Compliance Issues in a Quality Control Laboratory - Data Integrity, Out of Specifications (OOS), Corrective and Preventive Actions (CAPA)
Aug 2016
Analytical Methods in Development and Manufacture of Drugs and Biologics
Aug 2016
How FDA Trains Its Investigators to Review Sub-Systems for State of Compliance: What You Need to Do to Prepare for a Successful Inspection
Aug 2016
Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
Aug 2016
OIG Work Plans: How They Impact Providers
Aug 2016
FDA Compliance and Clinical Trial Computer System Validation
Aug 2016
FDA Scrutiny of Purchasing/Supplier Controls
Aug 2016
Creating Reader-Focused Technical Documents in FDA Regulated Industries
Aug 2016
FDA`s Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies
Jul 2016
Life Sciences Risk Management A to Z - Best Practices for Effectiveness and Efficiency: 2-Day Workshop
Jul 2016
Pharmaceutical Supply Chain Integrity - Good Distribution Practices (GDP)
Jul 2016
Design of Experiments for Process and Product optimization
Jun 2016
Global Regulations for Equipment Qualification and Validation of Processes in the Pharma Manufacturing
Jun 2016
Overview of clinical drug development from final preclinical selection, marketing approval, all phases of clinical trials, new strategies, challenges and solutions
May 2016
Project management tools to improve productivity and compliance in Analytical laboratories
Feb 2016
Creating Effective SOP for Regulatory Compliance
Jan 2016
Managing FDA Inspections from Readiness through Follow Up Responses
Jan 2016
Compliant Clinical Research Conduct: What Every Clinical Research Professional Needs to Know
Jan 2016
Process Robustness: The New FDA Paradigm
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
Pharmaceutical Water Use and Monitoring
Dec 2015
Objectionable Microorganisms: Considering the Risk
Dec 2015
Regulatory Crisis Management: Best Practices for Dealing with the Common Crisis Events for the FDA-Regulated Industry
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
Building a Vendor Qualification Program for FDA Regulated Industries
Nov 2015
How to Prepare for, Manage, and Follow-up to an FDA Inspection: Risk-driven Approach
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
Computer System Validation - Reduce Costs and Avoid 483
Oct 2015
Best Strategies for Meeting US (IND through Post Marketing) Drug Safety Requirements Efficiently
Oct 2015
GMP Validation Workshop | Learn to create your own workshop and private sessions
Oct 2015
Computer System Validation - Reduce Costs and Avoid 483
Oct 2015
Veterinary Drug Approvals: Practical Considerations for Conducting FDA-Required Regulated Studies
Oct 2015
How to Prepare for an FDA Meeting: Making the Most of Pre-IND/IDE, pre-NDA and Other Critical Meetings
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
Auditing QC and Contract Laboratories for GMP Compliance
Sep 2015
Steering Clear of DOJ’s Most Likely to Be Caught List
Sep 2015
How to Transition from Paper to Electronic Records in a Regulatory Environment
Sep 2015
Computer System Validation - Reduce Costs and Avoid 483s: 2-day In-person Seminar
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
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
USP Hot Topics: What`s Hot Now and How to Track Coming Changes and Influence USP
Jul 2015
The Future of OTC Drug Regulation and the Monograph Process
Jul 2015
Technical and Regulatory Writing for FDA Regulated Industries
Jul 2015
Learning from Recent FDA Warning Letters Related to Part 11 and Computer Validation
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
Optimal Resource Allocation and Capacity Planning for Biopharma and CRO
May 2015
CAPA, Failure Investigation and Root Cause Analysis - FDA Expectations
May 2015
FDA Guidance on RUO (Research Use Only)/IUO (Investigational Use Only) Products
May 2015
ICH Q10 - Moving From GMPs To A Pharmaceutical Quality System
Apr 2015
Regulatory Compliance for Dietary Supplements in the US, EU and Canada
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
Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts
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
Writing and Implementing Statistical Analysis Plans (SAPs) - Domestic and International Guidance under ICH E9
Apr 2015
Combination Drug/Device Products CGMPs - Final Rule
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
New Part 11 Guidance for Clinical Trials: What This Means for You
Mar 2015
Designing Effective and Efficient Extractables or Leachables Studies for Biologics
Mar 2015
Current Concepts and Challenges in Cloud Compliance
Mar 2015
Manufacturing and Marketing Cosmeceutical* and Homeopathic OTCs: Complying with FDA`s Rules for Drug Products that do not require FDA Pre-Approval
Mar 2015
How to Successfully Manage an FDA High Risk Inspection
Mar 2015
Institutional Review Boards (IRBs): The Changing Landscape and the Effect on the Conduct of Clinical Research
Mar 2015
How to Avoid an FDA Warning Letter with a Strong CAPA Program
Mar 2015
Monitoring Impurities in Pharmaceutical Products - ICH Q3 requirements
Mar 2015
Key GMP Systems in Pharmaceutical and Biotech Labs
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
Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
Feb 2015
Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials
Feb 2015
21 CFR 11 Compliance for Excel Spreadsheet
Feb 2015
Clinical Trial Liability Lawsuits
Feb 2015
Blinding of Investigational Materials
Feb 2015
Changing Supplier Controls Requirements
Feb 2015
A Bulletproof, Cost-efficient Supplier Management Program
Jan 2015
A Systematic Approach To Writing Effective Standard Operating Procedures (SOPs)
Jan 2015
EU Clinical Trial Regulation: New Requirements
Jan 2015
Pharmaceutical and Chemical Classification under the Harmonized Tariff Schedule
Jan 2015
Understanding and Implementing the Medical Device Directive
Jul 2014
Conducting Effective Investigation of Out-of-Specs and Atypical Laboratory Data
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
How To Translate Academic and Discovery Assays Into GLP Compliant Assays
Mar 2014
Establish Change Control for Pharmaceutical Stability Program
Mar 2014
Understanding ISO 13485 vs. ISO 9001 for Successful QMS in Medical Device Industries
Mar 2014
Remediating Pharmaceutical Water System Biofilm - What to Do After It Gets Ahead of You
Nov 2013
The Sunshine Act - Have you seen the light?
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
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
Residual Solvents - Understanding the Requirements and Practical Strategies for Compliance
Sep 2013
Understanding FDA and Avoiding Inspections Leading to Warning Letters, Seizures, Injunctions and Prosecutions
Sep 2013
Drug Law: Understanding the Essentials of FDA`s Authority over Innovative and Generic Pharmaceuticals
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
Using Statistical Methods for ICH Guidelines
Aug 2013
Regulatory Differences Between Biopharmaceutics and Medical Devices
Aug 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
FDA Warning Letter Closeout Program
May 2013
Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations: One and a Half-day In-person Seminar
May 2013
Conducting Successful FDA Meetings to Negotiate Product Development and Approval: 2-day In-person Seminar
Apr 2013
Overview of Combination Product Development for Pulmonary Drug Delivery
Apr 2013
Understanding Biofilm and Controlling It in Pharmaceutical Water Systems
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
Auditing the QC Microbiology Laboratory for FDA Compliance
Apr 2013
3-hr Virtual Seminar: Annual ICH GCP Refresher Course
Apr 2013
Design of Experiments in Biotechnology Analytical Development
Apr 2013
Designing a Clinical Protocol for Vaccine Clinical Trial
Apr 2013
Bioanalytical Methods Validation
Mar 2013
Defining And Managing User Requirements For Computer System Validation
Mar 2013
Raw Materials Risk Management in GMP Facilities: Avoiding GMP non-Compliance Due to Raw Material Issues
Mar 2013
Forecasting Clinical Study Enrollment and its Budget Considerations
Mar 2013
FDA`s Import Requirements and Managing the Import of FDA Regulated Products: 2-day In-person Seminar
Mar 2013
Complaint-Handling, MDR and Recall Management
Mar 2013
Global Medical Device Reporting - A Comparison of Worldwide Regulations
Mar 2013
21 CFR Part 11 Electronic Records: Electronic Signatures
Mar 2013
Obtaining Faster FDA 510(k) Approvals - The 510(k) as an Advocacy Document: One and a Half-day In-person Seminar
Mar 2013
Seeking Evidence in Clinical Trials in Hemoglobinopathy
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
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
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
Advanced Cell Culture & Fermentation - Process Development & Manufacture
Feb 2013
Clinical Study Enrollment Metrics and Their Financial Impacts
Feb 2013
The Clinical Trial Study Protocol (Advanced)
Feb 2013
Improve Supplier Quality (for Clinical Trial Projects) - Learn How to Implement a Robust Request for Proposal Process
Feb 2013
Marketing Compliance for Pharma Management
Feb 2013
The Caronia Court Decision and Off-Label Promotion
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
Best Practices in Responding to Form 483s
Feb 2013
Effective CAPA related to Managing Human Error
Feb 2013
Scientific Documentation: What Is It, How It Has to Be Evaluated, and How It Can Be Used?
Feb 2013
Social Media: Using The Legal Guideposts to Create Social Media Success (for Healthcare/Lifescience Companies)
Feb 2013
Investigator Initiated Trials - What Are We Doing to Ensure Human Subject Protection?
Feb 2013
Training on Current ICH GCP Guidelines
Feb 2013
GMP Analytical Laboratory Audits - Planning, Preparation, Execution, and Resolution
Feb 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
Quality Assurance at the (Clinical Research) Site: How to Develop a Manageable Plan
Dec 2012
Practical strategies to Improve Productivity in the Pharmaceutical Laboratory
Nov 2012
21 CFR Part 11 - Complete Manual for Compliance and Success
Nov 2012
Contamination-Control and Cleaning and Disinfection
Nov 2012
Introduction to Biotechnology Analytical Methods
Oct 2012
2-day In-person Seminar: Preparing IND Submissions for Conventional and Orphan Products
Oct 2012
Clinical Trials Drug Supply: Imports and Release Procedures for Shipping to Trial Sites
Oct 2012
CDISC – Insight, Impact and Implementation
Sep 2012
Clinical Trial Billing - Building a Compliant Process that Works!
Sep 2012
Risk Assessment-Compliance Using Easy To Fill Out Documentation
Sep 2012
How to Select Best Practices a CRO ?
Sep 2012
Investigator Initiated (Sponsored) Trials – ISSs
Sep 2012
Stability Studies for Vaccine Products
Sep 2012
Eliminate the Confusion – Analytical Method Qualification and Validation
Sep 2012
(QMS) Competence and Training Requirements per FDA QSR and ISO 13485
Aug 2012
Strategies for Preparing and Submitting Successful Citizen Petitions and Suitability Petitions to FDA
Aug 2012
Site Challenges in Conducting Investigational Device Trials
Aug 2012
Anticipated Changes to the EU Medical Device Directives; 2010 Changes and What the Future Holds for Licensees - Webinar By GlobalCompliancePanel
Aug 2012
Addressing Impurities in Pharmaceutical Products: Impurities, Degradants, Residual Solvents and Elemental Impurities
Aug 2012
How to Survive a DEA Inspection Series: DEA Due Diligence for Manufacturers and Distributors by onlinecompliancepanel
Aug 2012
The Use and Mis-use of FMEA in Medical Device Risk Management
Jul 2012
One and a Half-day In-person Seminar: FDA Compliant GLP for Nonclinical Studies - For Pharmaceutical and Medical Device Industries
Jul 2012
Strategic Selection and Development of Immunogenicity Binding Methods
Jul 2012
Ethics and Scientific Misconduct in Regulated Studies
Jul 2012
Software validation and 21 CFR Part 11 remediation planning: FDA inspection strategies
Jul 2012
Specialized Formulations – Biomolecules
Jul 2012
Changes to Good Pharmacovigilance Practices in the EU - Webinar By GlobalCompliancePanel
Jul 2012
Cleanroom Management – From a Microbial Perspective
Jul 2012
What Every FDA Regulated Company Needs to Know About its FDA District Office
Jul 2012
Navigating the Japan Regulatory and Clinical Trial Environment; Conducting Clinical Studies in Japan
Jul 2012
Clinical Trial Auditing - Identifying risks and building a more compliant and successful trial
Jul 2012
Obtaining and Marketing Your 510(k) with Today`s FDA, a 510(k) Workshop
Jun 2012
FDA’s Regulation of Veterinary Regenerative Medicine
Jun 2012
Recommendations for Cell Banks used in GXP testing - Webinar By ComplianceOnline
Jun 2012
Good Laboratory Practices for Bioanalytical Laboratories - Webinar By ComplianceOnline
Jun 2012
Process Validation - Webinar By ComplianceOnline
Jun 2012
The U.S. FDA`s New Global Engagement Initiative - Webinar By ComplianceOnline
Jun 2012
Understanding Costs of a Study for Clinical Trials - Webinar By ComplianceOnline
Jun 2012
REMS Update: Risk Evaluation and Mitigation Strategies - Webinar By ComplianceOnline
Jun 2012
Auditing Systems for 21 CFR Part 11 Compliance
Jun 2012
Practical Issues with Conducting Multi-National Clinical Trials for Medical Device Approval in the US
Jun 2012
Test Article Management and Characterization for Drugs and Devices - Webinar By ComplianceOnline
Jun 2012
Navigating the Japan and South Korean Regulatory Compliance and Clinical Trial Environment
Jun 2012
Unsolicited Drug and Device Off-Label Claims Via Social Media and Risk Management
Jun 2012
The 21 Elements of a 510(k) - Webinar By ComplianceOnline
Jun 2012
What Are the Current Tools and Best Techniques for (Clinical Trial) Audit/Inspection Preparedness?
May 2012
Making Sense of FDA’s (proposed) Rules for the Development and Approval of Biosimilars
May 2012
The A to Z’s of Microbial Control, Monitoring and validation of Pharmaceutical Water Systems
May 2012
Pre-Approval Statements and Representations by Pharmaceutical Manufacturers
May 2012
An Overview of Risk Management and Risk Analysis Techniques in Clinical Trials
May 2012
Supplier Controls to Meet Tougher U.S. FDA Requirements
May 2012
Cosmetics – How Are they Regulated?
May 2012
FDA Concerns on Alarm Standards and Safety
May 2012
Statistics in Pharmaceutical Quality Control
May 2012
Equipment Calibration in FDA QSR – Regulations and Warning Letters
May 2012
Pre-Formulation and Formulation Development of a Sound Bio Pharmaceutical Formulation that is cGMP Compliant
May 2012
How to Format Succinct and Comprehensive 510(k)s and PMAs
Apr 2012
Physician Payment Sunshine Act and State Sunshine Law Compliance. Are you Prepared for the New Federal Requirements and Existing State Requirements?
Apr 2012
The Hero of Manufacturing Contamination Control - The Microbiology Lab
Apr 2012
DEA, Your Registration and How to Lose It
Apr 2012
Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies - Application and Compliance to Ensure Safety of Biologic Therapeutics and Medical Devices
Apr 2012
2-day In-person Seminar: Introduction to Design of Experiments for Process Characterization
Apr 2012
Acceptance Activities in FDA QSR - Regulations and Warning Letters
Apr 2012
Issue Detection and Escalation in Clinical Trial Settings
Apr 2012
Validation and Use of Excel Spreadsheets in Regulated Environments
Apr 2012
Quality Agreements with Pharmaceutical/ Biologic Manufacturers and the Use of Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities
Mar 2012
Foreign Manufacturing Facilities – Avoiding Problems with FDA
Mar 2012
Best Practices for Maintaining an IND and IDE Application with FDA
Mar 2012
Regulatory Barriers for the Implementation of Pharmacogenomics for Personalized Medicine
Mar 2012
How To Establish An Effective Good Clinical Practice in Drugs and Medical Devices
Mar 2012
Doing Business Despite Embargoes and Sanctions: OFAC Licensing
Mar 2012
Understanding Disinfection and Cleanroom Cleaning in a FDA Regulated Environment
Mar 2012
Validation of Bioanalytical Methods and Procedures for FDA Compliance
Mar 2012
FDA`s Rules for Financial Disclosure in Clinical Trials Clarified: New Guidance, Practical Application
Mar 2012
Managing Immunogenicity Risk in Biopharmaceuticals
Mar 2012
Webinar: When Do You Need a 510K?
Mar 2012
Method Validation in Drug Development Process - Common Mistakes and Issues
Mar 2012
Audit/Inspection Preparedness for Clinical Research/Site Coordinators
Mar 2012
Software Verification and Validation Planning and Implementation
Mar 2012
Validation of Analytical Procedures for Use in the Pharmaceutical Industry
Feb 2012
Submission Documentation for Sterilization Process Validation - A Comprehensive View of Content for an Approvable CMC Section
Feb 2012
FDA’s Current Thinking for Industry cGMPs for Phase 1 INDs
Feb 2012
Does your pharmaceutical lab have GMP and non-GMP functions?
Feb 2012
Prepare for Tougher cGMP Compliance Audits - Webinar By GlobalCompliancePanel
Feb 2012
Solutions for Addressing Fungal and Bacterial Spore Outbreaks in Pharmaceutical, Biotech, and Medical Device Operations
Feb 2012
Clear as Mud: Obtaining & Marketing your 510(K) with Today`s FDA
Jan 2012
The Evolving State of U.S. Sanctions Against Iran
Jan 2012
Introduction to the Electronic Common Technical Document
Jan 2012
Preparing for FDA GCP Inspections – Essentials for Sponsor Companies
Jan 2012
Analytical Procedures and Procedures Transfer
Jan 2012
Validation and use of Access Databases in FDA regulated environments
Jan 2012
New Dietary Ingredients in the Regulatory Scheme
Jan 2012
Troubleshooting Microbial Excursions in Pharmaceutical and Biotech Operations
Jan 2012
SOPs for Clinical Trials – Regulatory Requirement and Key to Effective Management
Jan 2012
Purposeful Water and Steam System Validation – Not Just A Regulatory Requirement
Jan 2012
An Introduction to the FDA New Drug Approval Process
Jan 2012
Introduction to FDA Good Documentation Practices
Jan 2012
Major CGMP Issues for
Jan 2012
Proven Root Cause Investigation Techniques for Pharmaceutical Water Systems
Dec 2011
FDA Validation Requirements - Webinar By ComplianceOnline
Sep 2011
Drug Master Files - Understanding and Meeting your Global Regulatory and Processing Responsibilities
Sep 2011
Investigator responsibilities and Legal commitments in Drug and Device Clinical Research
Sep 2011
Responding to FDA Form 483s and Warning Letters - Webinar By ComplianceOnline
Sep 2011
Common GCP Violations and Site Mistakes - How to Avoid them
Aug 2011
Preparing for an FDA Pre-Approval Inspection - Webinar By ComplianceOnline
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
Clinical Project Management - Webinar By ComplianceOnline
Aug 2011
The latest FDA and EMA hot area for citations, warning letters and other actions
Aug 2011
Vendor Qualification - Designing and Implementing an Efficient and Compliant Vendor Program
Aug 2011
Trial Master File for Research Sites: Can You Pass FDA Inspection?
Aug 2011
Full day Virtual Seminar on Pharmaceutical Stability - Webinar By ComplianceOnline
Jul 2011
Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11
Jul 2011
Vendor Qualification Auditing for FDA Computer System Compliance - Webinar By ComplianceOnline
Jul 2011
Clinical Document Management and Collaborative Electronic Data Exchange in Clinical Trials
Jul 2011
The Investigational Medicinal Product Dossier (IMPD): EU`s CTA vs. FDA`s IND
Jul 2011
Advertising and Promoting FDA Regulated Products - Webinar By ComplianceOnline
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
How to Meet HIPAA-HITECH Encryption Requirements - Webinar By ComplianceOnline
Jul 2011
Using the USP Effectively - 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
Navigating the new FDA world of Combination Products
Jun 2011
Designing an effective cleaning validation in today`s regulatory environment
Jun 2011
Sterilization Options for Challenging Products
May 2011
Lyophilization Process Development and Cycle Design
May 2011
`The Right Stuff` – Implementing Quality Control Tools in Quality Systems Operations
May 2011
Retirement of Computer Systems: Strategies for FDA Compliance and Tools for Implementation
May 2011
Residual Moisture Testing - Proven Techniques
May 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
Avoiding `Failure to Investigate` - Observations by Conducting Effective Investigations
Apr 2011
The 510(k) Process and Risk Management
Apr 2011
Salmonella: Evolution, Epidemiology, Detection and Control
Apr 2011
Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP
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
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
How to secure GCP compliance in Clinical Trials: The complete overview of the critical parameters 2010
Feb 2011
Software Verification and Validation Planning and Execution
Feb 2011
Eliminate the Confusion –Annex 13 GMP guide
Feb 2011
Full Day Virtual Seminar : Annual GLP Refresher Course
Feb 2011
21 CFR Part 212: Quality Systems to Ensure cGMP Compliance
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
Ethics, Standards and Identifying Risks in Clinical Research - ComplianceOnline Clinical Training
Jan 2011
Full Day Virtual Seminar - Understanding Biofilm and Controlling It in Pharmaceutical Water Systems
Jan 2011
Medical Device Complaints Handling Strategies for Managing Your Biggest Compliance Challenge
Jan 2011
Full day Virtual Seminar - Compliance for 21 CFR Part 11, reducing costs using risk-based computer system validation
Jan 2011
Anatomy of a Medical Device Inspection: From EIR to 483 to Warning Letter
Jan 2011
cGMP: Strategies for implementation and compliance for Phase I Investigational Drug and Biologic products
Jan 2011
Clear as Mud: Obtaining and Marketing Your 510(k) With Today`s FDA San Francisco
Jan 2011
Clear as Mud: Obtaining and Marketing Your 510(k) With Today`s FDA Irvine
Jan 2011
Establishing Global Drug Substance and Drug Product Specifications – What the Guidelines Don’t Tell You
Jan 2011
Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities - ComplianceOnline Pharmaceutical Training
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
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
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
Meeting the FDA: How to get the best advice from the FDA - ComplianceOnline FDA Training
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
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
Validation Basics A-Z: Planning, Implementing & Maintaining
Oct 2010
ComplianceOnline Virtual Seminar - 21 Cfr Part 11: Complete Manual For Compliance Success
Oct 2010
Using Social Media in a FDA Compliant Manner
Oct 2010
The Tougher U.S. FDA - One Year Later
Oct 2010
ComplianceOnline Webinar - Preparing for and handling FDA Laboratory GMP inspections
Oct 2010
Data Monitoring Committees (DMCs) effect on subject safety in clinical research and how to set it up to be effective
Oct 2010
What exactly is required for 21 CFR Part 11 compliance?
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
ComplianceOnline Webinar - GMPs in Biopharmaceutical Development Laboratories
Oct 2010
Best Practices for Managing FDA Investigators and Handling FDA 483 Observations
Sep 2010
Ensuring GCP compliance through quality auditing in clinical trial
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
The ICF Process: Tips on Achieving Optimal compliance and Comprehension
Sep 2010
ComplianceOnline Webinar - Medical Device Changes and The 510(k)
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
Developing Supplier Quality Auditor Training Programs
Sep 2010
Risk Assessments - Key to a Viral Safety Management Plan
Sep 2010
The role of Analytical Program to Support Drug Development Process
Sep 2010
Key Factors to Write an Effective Standard Operating Procedure (SOP)
Sep 2010
Engineering and Laboratory Mythology with Water System
Sep 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

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