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The Medical Device Summer School - From Concept to CE Marking
Dec 2024
Audits - Self/Internal, Vendor and Regulatory Inspections
Nov 2024
Drafting and Negotiating Clinical Trial Agreements
Nov 2024
Leachables and Extractables MasterClass - EU
Oct 2024
Post-Authorisation Safety Studies MasterClass- EU
Sep 2024
Global Meet on Pharmaceutics and Drug Delivery Systems (GMPDDS)
May 2024
GCP Inspection Readiness
Dec 2023
Implementation of a Successful Technology Transfer Process
Nov 2023
Data Driven Approach in Clinical Trials
Sep 2023
Smart(er) Biomanufacturing: Evaluating the Risks and Opportunities
Sep 2023
Sri Lanka Medical Association (SLMA) International Medical Congress
Jul 2023
Clinical Trials Quality & Inspection Updates
May 2023
The Hermina International Conference on Health (HICH)
Feb 2023
Clinical Data Disclosure and Transparency Summit
Feb 2023
International Congress on Biomedical and Bio Instrumentation (ICBBI)
Feb 2023
Life Sciences, Clinical Trials, Patient Recruitment & Retention
Jan 2023
International Conference on Drug Discovery and Drug Development
Nov 2022
Technical Documentation to Comply with the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation)
Nov 2022
International Conference on Healthcare Engineering (ICHE)
Sep 2022
PK/PD in Drug Discovery and Development for the US market MasterClass
Sep 2022
Analytical Instrument Qualification & Validation - Use of Excel and FDA Audit Preparation
Jul 2022
Pre Event Respiratory Drugs
Jun 2022
JAK Inhibitors Drug Development Summit
Jun 2022
Medical Writing & Communication Strategy
May 2022
Medical Device Regulations & Compliance Summit
May 2022
Pharmaceutical and Medical Device Ethics and Compliance Congress
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
Clinical Trial Regulation MasterClass
Apr 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
Congress on Cardiology and Cardiac Surgery
Feb 2022
The EAAR Conference on New Medical Device Regulations (RMD2022)
Feb 2022
Speaker Programs and Advisory Boards
Jan 2022
UCG on Diabetes and Endocrinology Conference
Jan 2022
Cleaning Validation for Pharma
Dec 2021
FDA Pharmaceutical Labeling Boot Camp
Dec 2021
Aesthetic & Cosmetic Regulatory Events Summit (ACRAS)
Nov 2021
Regulatory and Technology Considerations for the Design of Medical Device Software MasterClass
Nov 2021
Vendor/CRO Management and Oversight MasterClass
Nov 2021
Medical Device Digi Expo
Oct 2021
Edition Injectables Summit
Oct 2021
Combination Products Summit
Oct 2021
Temperature Control and Logistics US
Sep 2021
Xcelerate at Biotech Week Boston
Sep 2021
National - Strategy Summit on Paragraph IV Litigation
Sep 2021
Advanced Precision Medicine MasterClass
Sep 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
Digital Transformation Journey for Medical Affairs
Jun 2021
Bangladesh Medical & Healthcare Virtual Expo
Jun 2021
Decoding Digital Health for Life Sciences
Jun 2021
Clinical Trial Supply Forum
May 2021
Asia-Pacific Pharma Congress
May 2021
Personalized and Precision Medicine International Conference (PEMED)
Apr 2021
Latin America - Understanding Regulatory Compliance Requirements Across the Life Science Industry (Focus: Brazil, Mexico, Argentina)
Apr 2021
Sri Lanka Medical & Equipment Virtual Expo
Mar 2021
Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices
Mar 2021
New Medical Device Regulation
Mar 2021
Supply Chain Re-Innovation: Life Sciences
Mar 2021
Drug Delivery Devices Symposium
Mar 2021
Risk Management in Medical Devices Industry
Mar 2021
Ventricular Assist Device (VAD) CME Symposium for Community Partners
Feb 2021
International Conference on Clinical Trials
Feb 2021
FDA`s Medical Device Software Regulation Strategy
Feb 2021
Software Design for Medical Devices (SDMD) Global
Feb 2021
EC Medical Devices Vigilance System and Post Marketing Surveillance
Jan 2021
Data Integrity: FDA/EU Requirements and Implementation
Jan 2021
Endpoint Adjudication
Dec 2020
Clinical Trial Innovation Summit
Nov 2020
Product Complaints and Recalls Virtual Summit
Nov 2020
Essentials Of USP Microbiology - For Those Who Are Not Microbiologists or Who Wish A Refresher
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
BODYNETS - EAI International Conference on Body Area Networks
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
DigiHealthSouth - EAI International Conference on Digital Healthcare Technologies for the Global South
Oct 2020
Project Management for FDA-Regulated Companies
Oct 2020
Digitalpathology
Oct 2020
Virtual ISPOR-FDA Summit
Sep 2020
WIRED Health:Tech
Sep 2020
World Congress on Plasma Chemistry and Plasma Processin
Sep 2020
FWD Pharma
Sep 2020
International Virtual Conference on Public Health (IVCPH)
Aug 2020
Life Science Regulatory Information Summit
Aug 2020
European Congress on Vaccines R&D & Vaccination
Aug 2020
Pharma Packaging and Labelling Europe
Jun 2020
Implementing a Bullet Proof Quality System for FDA Audit Success
Jun 2020
Predictive Analytics World Healthcare
May 2020
EU Medical Device Regulation (MDR) Updated CE Marking Process and ISO 13485: Expectations
Feb 2020
You have a BI Positive or Product Sterility Positive - Now What
Nov 2019
Confidentiality of Substance Use Disorder Patient Records; Complying with the New Federal Law 42 CFR Part 2
Nov 2019
CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE
Sep 2019
How to Investigate Environmental Monitoring Excursions
Sep 2019
Human Factors Engineering to Satisfy the New IEC 62366-1, -2
Aug 2019
Effective Standard Operating Procedure (SOPs) Development
Aug 2019
Adjustable Rate Mortgage (ARM) Rule
Aug 2019
Effective Supplier Management Programs
Aug 2019
Is Your Medical Device Software 510k Ready
Aug 2019
Death by CAPA Does your CAPA Program need a CAPA
Jul 2019
Process Validation - Overview of Why and How
Jul 2019
6 Most Common Problems in FDA Software Validation and Verification
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
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
FDA Quality System Inspection Technique (QSIT) Audits – Good Preparation Practices
Jun 2019
FDA Off-Label Promotion Guidelines
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
Supplier and Service Provider Controls: FDA Expectations
May 2019
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs
May 2019
FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs
May 2019
Validation and Use of Excel Spreadsheets in FDA Regulated Environments
May 2019
Texting and Mobile Devices in Healthcare - HIPAA and CMS Requirements for Security of PHI
May 2019
The Value of a Human Factors Program
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
Production and Process Controls - Ensuring your medical device conforms to its specifications
May 2019
Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU`s MDD Requirements
May 2019
Effective Records Management and Document Control for Medical Devices
May 2019
Compliance Measures for Case Managers
May 2019
In-Depth Testing of Computer Systems Regulated by FDA
Apr 2019
Essentials of Validation - IQ, OQ, PQ
Apr 2019
Ensuring your Site is Ready for an FDA Inspection
Apr 2019
Risk Management in Clinical Research
Apr 2019
Medical Device Laws and Regulations in Asia - Part 2 - India, Japan, and Korea
Apr 2019
HIPAA and Having a Compliant Front Office
Apr 2019
FDA`s New Import Program for
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
ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements
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
Process Challenge Device Development for EO Sterilization
Mar 2019
FDA Inspections - Do`s and Don`ts
Mar 2019
Export Certificate for Medical Devices - Out Your Competition!
Mar 2019
The DIOM – A Straightforward Method for Meeting FDA Requirements for Design Inputs and Outputs
Mar 2019
EU and US GMP/GDP – Similarities and Differences
Mar 2019
Trends for Computer System Validation, Medical Device Compliance and FDA Enforcement
Mar 2019
3-Hour Virtual Seminar on FDA`s Scrutiny of Social Media Promotion
Mar 2019
The FDA Inspection: Preparation, Management, and Follow - up
Mar 2019
510(k) Update - How to Format Succinct and Comprehensive 510(k)s
Mar 2019
Water System Biofilm Control and Microbial Monitoring Myths
Mar 2019
505(b)(2) NDAs
Feb 2019
Medical Device Employee Training - Requirements and Implementation Tips
Feb 2019
Establishing a Medical Device Security Program
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
Measurement Systems Analysis
Feb 2019
Design Verification, Validation and Testing for Medical Devices
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
Understanding FDA Design Verification and Validation Requirements for Medical Devices
Feb 2019
Complaint Handling, MDR`s & Recalls
Feb 2019
Virtual Seminar on Master Validation Plan - The Unwritten Requirements
Jan 2019
Medical Device Cybersecurity and FDA Compliance
Jan 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
Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error
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
Designing an Effective Cleaning Validation for Reusable Medical Devices in Today`s Regulatory Environment
Dec 2018
In a Nutshell: Data Protection & Privacy Legislation in the U.S. & European Union
Dec 2018
Meet the Tougher U.S. FDA CGMPs
Nov 2018
Requirements for IQ, OQ and PQ Quality Protocols
Oct 2018
Metrology: Statistical Analysis of Measurement Uncertainty
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
Advanced Search Webinars EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations
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
Tougher Supplier Controls – Avoid Unwanted Changes
Sep 2018
Auditing and Qualifying Suppliers and Vendors
Sep 2018
Successful Computer System Validating and Control Using Managed Services SaaS, and Cloud Based Platforms
Sep 2018
Writing Effective Analytical Procedures
Sep 2018
FDA`s New Enforcement of 21 CFR Part 11
Sep 2018
How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
Sep 2018
Quality Agreements Made Easy
Sep 2018
Chipping away at constraints – Practical tips to Improve your Manufacturing Operations
Sep 2018
Compliance for Risk Based Approaches for Clinical Trials
Sep 2018
Medical Device Cybersecurity -Improving Compliance and your Company`s Bottom Line
Sep 2018
Laboratory Controls – Anticipate the Systems Based FDA Inspection
Sep 2018
Marketing to Medicare or Medicaid Beneficiaries - What You Can and Cannot Do
Aug 2018
Purchasing Controls for Medical Devices
Aug 2018
What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections
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
Laboratory Investigations for Out of Specification Results
Jul 2018
Sunshine Act Reporting: Clarification for Clinical Research
Jul 2018
Onboarding In A GMP Environment – Best Practices
Jul 2018
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
Jul 2018
How to Make Sure Your Foreign Vendors are FDA Compliant and Stay that Way
Jul 2018
Project Management for FDA-Regulated Companies
Jul 2018
Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions
Jul 2018
Patients Suing Under HIPAA
Jul 2018
Ligature Risks: Ensuring Compliance with the CMS Hospital CoPs and TJC Requirements
Jun 2018
510(k) Documentation Best Practices for Software or Software Enabled Medical Devices
Jun 2018
Biocompatibility Testing; what you need to know
Jun 2018
Food Fraud in the Organic Industry
Jun 2018
Overview of Medical Device Regulation in Europe
Jun 2018
Oversight of CROs-Vendors-CMOs
Jun 2018
Why and How - Verification of Compendial Methods - USP [1226]
May 2018
Gaining and Re-Establishing Control of Your Cleanroom
May 2018
Investigator Reporting Responsibilities: AEs, Unanticipated Problems, Modifications, and Deviations
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
Fundamentals of Risk Management in Clinical Research
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
Analytical Method Validation
Mar 2018
Essentials of Dealing with Non-Conforming Material
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
Management Control - Underutilized and Underappreciated
Feb 2018
Acceptance Activities in FDA QSR
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
Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigation
Feb 2018
Validation of FDA-Regulated Computer Systems
Feb 2018
Trial Master File for Clinical Data Systems Regulated by FDA
Jan 2018
The Value of a Human Factors Program
Jan 2018
21 CFR Part 11 Compliance - Ensuring Data Integrity and Safety in Clinical Research
Jan 2018
Excel Spreadsheets - Step-By-Step Instructions for Compliance
Dec 2017
Integration of ERP and Legacy FDA-Regulated Systems
Dec 2017
Why are we Seeing More Independent Data Safety Monitoring
Dec 2017
Dealing with Performance Issues
Nov 2017
FDA`s Latest Regulations for Tobacco Industry Effective 8-2016
Nov 2017
AAMI TIR 45: Agile Meets Software Standards, and we all Win
Nov 2017
Medical Device Hazard Analysis Following ISO 14971
Nov 2017
The Future of Supply Chain - 7 Megatrends that will Transform the Global Marketplace
Nov 2017
Virtual Seminar on Analytical Method Validation Process
Nov 2017
World Clinical Medicine & Collaboration Forums
Oct 2017
Laboratory Instrument Qualification
Oct 2017
Managing Your FDA '483' Inspectional Observations
Oct 2017
Developing the Risk Management File
Oct 2017
Medical Device Engineering Change Control
Oct 2017
Japan - Regulatory Filing Requirements and Compliance Processes for Medical Devices
Oct 2017
21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
Oct 2017
Standards for Medical Device Software: Friend, not Foe
Oct 2017
Effective Training Practices for FDA Compliance
Sep 2017
Best Practices for an Effective Cleaning Validation Procedures
Sep 2017
FDA`s Medical Device Clinical Trials Program
Aug 2017
Excel Workbooks and FDA Device Regulations
Aug 2017
Device Accessories - Understanding and Implementing the Final Guidance Document
Aug 2017
Medical Device Hazard Analysis Following ISO
Aug 2017
FDA Regulations for Environmental Monitoring (EM) Program
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
Understanding Aseptic Technique and Cleanroom Behavior
Jul 2017
Personnel Training to Assure FDA and ISO Compliance
Jul 2017
Statistical Concepts of Process Validation
Jul 2017
How To Establish an Effective Chief Compliance Officer`s (CCO) or Chief Risk Officer`s (CRO) Function - Organization and Responsibilities
Jun 2017
Writing Effective Standard Operating Procedures and Work Instructions
Jun 2017
Medical Device - Engineering Change Control
Jun 2017
Cleaning Validations Using Extraction Techniques
Jun 2017
Healthcare Medical Software/Applications - Risks, Validation & Interoperability
Jun 2017
FDA Policy and Goals Regarding the 483 Response
Jun 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
Medical Device Reporting Requirements for Manufacturers Final Guidance
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
Medical Records: Responding to Subpoenas and Investigations
Apr 2017
Medical Device Recalls: a Preventive Strategy
Apr 2017
PMBA - Project Management Business Administration
Apr 2017
Effective Purchasing and Supplier Controls for Medical Device Manufacturers
Apr 2017
Efficient and Effective FDA and ISO Management Reviews
Apr 2017
Packaging and Labelling for Clinical Products
Apr 2017
Medical Device Premarket and Post market Cyber security following the new FDA Guidances
Apr 2017
Preparing a US FDA Medical Device 510(k) Submission and Deciding When to Submit a 510(k) for a Change to an Existing Device
Apr 2017
Medical Necessity: Can you define it, Capture it, Document it
Apr 2017
Insight into Requirements of PMDA for Marketing Medical Products in Japan
Mar 2017
Data Analysis in QSR
Mar 2017
Classifying Medical Devices - US and EU
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
Powers of Attorney: Medical Records Release Concerns
Feb 2017
Clinical Trial Monitoring: A Sponsor Responsibility
Feb 2017
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico
Feb 2017
Understanding Design Controls
Feb 2017
Spotlight on Post Market Surveillance
Feb 2017
Microsoft Excel Series - Part 2: Learn More about Macros
Feb 2017
Three-dimensional cell culture: Innovations in tissue scaffolds and biomimetic systems
Feb 2017
How to conduct a Human Factors and Usability validation following ISO62366 and the new FDA Guidance
Feb 2017
Techniques for Medical Device Packaging
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
Requirements for Registration of Medical Device Products in China
Jan 2017
The Sunshine Act: Reporting for Clinical Trials
Jan 2017
Microsoft Excel Series - Part 1: Shake Hands with Macros
Jan 2017
Chemistry 101 for Medical Device Regulatory & Quality Professionals: Essential knowledge needed to Manage Drug&Device Combination Product Project
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
Implementation of Risk Evaluation and Mitigation Strategy (REMS) Programs in a Health System
Jan 2017
HIPAA Breach Notification Rule - What you must do to Comply
Jan 2017
The New FDA-Product Approval, Inspection, and Enforcement
Jan 2017
Fundamentals of the de novo process for medical devices: What you need to know when pursuing a de novo application and approval with the FDA
Jan 2017
Effective Corrective and Preventive Action Program (CAPA): The Role of Corrective Action and Preventative Action in Your Quality Management System
Jan 2017
Navigating the New European Clinical Trial Regulation (EUCT Regulation 536-2014)
Jan 2017
Corrective and Preventive Action (CAPA)
Jan 2017
How to Handle HIPAA Security Incidents Breaches, Complaints, and Investigations
Dec 2016
Quality and Compliance - Building Your Key Capabilities for Future Success
Dec 2016
Clinical Evaluation Reports (CER`s) Required for All Medical Devices in Europe
Dec 2016
Device Master Record - Can DMR show the way to comply with QSR?
Dec 2016
Product Risk Management Under ISO 14971:2007 and ICH Q9
Dec 2016
How to Manage a Medical Device Recall Efficiently and Effectively
Nov 2016
510(k) Preparation with New Released FDA Guidance on Product Modifications
Nov 2016
Effective Complaint Handling & Medical Device Reporting
Nov 2016
Preparing for the Upcoming EU Medical Device Regulations
Nov 2016
HIPAA Security & Privacy Risk Analysis- OCR Audits
Oct 2016
Laboratory Instrument Calibration: Current FDA Regulatory Requirements and Best Practices
Oct 2016
Medical Device CE Mark & Quality System Certification: Recent & Proposed Changes
Oct 2016
Design and Execution of Stability Studies for Biologics
Oct 2016
Auditing Clinical Trials for Good Clinical Practice (GCP) Compliance
Oct 2016
Test Methods and Standards for Medical Device Design Verification and Validation
Oct 2016
MEDDEV 2.7.1, Revision 4 for Clinical Evaluation and the Latest Guideline: A Guide for Manufacturers and Notified Bodies
Oct 2016
Learning Design Controls through Review of FDA 483 Observations
Oct 2016
HIPAA Training for the Compliance Officer
Oct 2016
Production and Process Control: Building a Robust System for Medical Device Companies
Oct 2016
Technical Writing for Medical Products: SOPs, Investigations and Change Records
Sep 2016
Setting and Measuring Quality Objectives
Sep 2016
Medical Record Standards: What Hospitals Should Know About the CMS Hospital CoPs
Sep 2016
How to prepare for and Host FDA Inspection and Avoid 483`s
Sep 2016
Medical Device Tracking: Latest FDA Update and Expectations
Sep 2016
Handling, Storage, Distribution, and Installation of Medical Devices
Sep 2016
FDA Regulation of Digital Health - Current Status and Recent Developments
Aug 2016
Business Continuity or Disaster Recovery Planning
Aug 2016
EHS Incident Prevention - Proactive EHS Programs
Aug 2016
Risk Based Approach for Medical Device Design Control
Aug 2016
Chiropractic & ICD-10
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
Changes to the Common Rule (45 CFR 46) : What this means for you
Aug 2016
How to do a Risk Analysis
Aug 2016
How to Prepare for Increased HIPAA Enforcement
Aug 2016
FDA`s Emerging Signals Guidance: Reporting Medical Device Safety Warnings
Jul 2016
FDA Issues Draft Guidance for 3D Printed Medical Devices
Jul 2016
Using Analysis of Variance (ANOVA) - A Practical Approach
Jul 2016
Standards and Their Role in Medical Device and Patient Safety
Jul 2016
Human Factors/Usability Based on ISO 62366
Jul 2016
FDA QSR Training (21 CFR Part 820) for Medical Device Companies
Jul 2016
Good Documentation Practices (GDP)
Jul 2016
USP <71> Sterility Testing: New Harmonization with International Compendia and Overview
Jul 2016
Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries
Jun 2016
FDA`s Low-Risk Device Policy and the Impact on Mobile Medical Device Applications
Jun 2016
Analytical Method Validation under Good Laboratory Practices (GLPs)
Jun 2016
Complying With Telemedicine Requirements
May 2016
Adverse Event Reporting: Site and Sponsor Reporting Requirements for Investigational Products
May 2016
An Ethical Use of Electronics, EHR, and e-Anything
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
Risk Management for Medical Devices
Apr 2016
Best Practices for Compliance with FDA 21CFR1040
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
Integration of ERP and Legacy FDA-Regulated Systems
Apr 2016
Evaluating the Effectiveness of a Corporate Compliance Program
Mar 2016
Device Changes and the 510(k)
Mar 2016
Root Cause Analysis - The Heart of a Successful CAPA Program
Feb 2016
Creating Effective SOP for Regulatory Compliance
Jan 2016
Medical Devices Designing with Cleanliness in Mind
Jan 2016
Medicare Penalties and Incentives – Update for Medical Practices
Jan 2016
Investigational Device Accountability
Jan 2016
How to Develop a Master Validation Plan
Jan 2016
Toyota Kata - Wax On, Wax Off (in partnership with ASQ Lean Enterprise Division)
Jan 2016
Complaint Handling & Medical Device Reporting (MDR)
Jan 2016
FDA`s New Enforcement of 21 CFR Part 11
Jan 2016
FDA`s Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List
Jan 2016
FDA Inspection Lessons Learned: Lack of Trial Oversight
Jan 2016
How to Respond to an FDA Investigation: What happens when the FDA threatens to shut you?
Jan 2016
HIPAA - Portable Devices and Enforcement
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
Developing a Validation Master Plan
Dec 2015
Corrective and Preventive Action (CAPA) and Complaint Handling in Medical Device.
Dec 2015
Objectionable Microorganisms: Considering the Risk
Dec 2015
Effective Strategy for Medical Device Recalls
Nov 2015
ICH-FDA Good Clinical Practice – Managing Clinical Trials
Nov 2015
Development regulatory affairs for Oncology Medicinal Products
Oct 2015
Product Stability Testing Program - Designing and Sustaining New and Existing Programs
Oct 2015
Medical Device Export Approvals and Certificates in compliance with FDA regulations
Oct 2015
CAPA Training and Causes of Warning Letters due to Lack of Comprehension
Oct 2015
A look at 510(k) changes
Oct 2015
Combination Products: FDA`s Final Rule for GMP Requirements and Introduction and Expectations for `Combo` Products
Oct 2015
Establishing an FDA-Compliant UDI System
Oct 2015
Risk Management in Clinical Trials
Oct 2015
Orphan Medicinal Product Designation in the EU
Sep 2015
Risk-based Supplier Management System: ImpactImpact on Regulatory and Operational Goals for Medical Device Manufacturers
Sep 2015
Product Risk Management - ISO 14971:2007
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
Cleaning Validations Using Extraction Techniques
Sep 2015
The Role of FDA in Health Care Software Regulations and Development
Sep 2015
Creating Design History Files (DHF), the Device Master Records (DMR) and the Device History Records (DHR), Utilizing the Principles of Lean Documents and Lean Configuration
Sep 2015
Designing Medical Devices for Long Life at Lower Costs
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
Conformance of Design History Files for Mature Medical Devices
Sep 2015
The FDA’s DHF, DMR and DHR Design Dossier for Documentation
Sep 2015
FDA`s enforcement of 21 CFR part 11 compliance
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
Key Considerations in Verification & Validation of Medical Devices
Aug 2015
Medical Device Reporting (MDR)
Aug 2015
PREPARING FOR IMMINENT FEDERAL HIPAA AUDITS (LEVEL:ADVANCE)
Aug 2015
Preparing for Imminent Federal Hipaa Audits (level:intermediate)
Aug 2015
Medical Device Registration & Listing, and Inspection Follow-up Activities
Aug 2015
Supplier Quality Agreements - Essential for Suppliers of Many Outsourced Processes
Aug 2015
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs
Aug 2015
How To Conduct Medical Device Risk Analysis Effectively (level: Advance)
Aug 2015
Failure Mode and Effects Analysis for Design Improvement and Design Control
Aug 2015
Understanding the Mobile Medical Applications Guidance
Aug 2015
How to Survive an FDA Inspection
Aug 2015
European Filing and Registration Procedures
Jul 2015
FDA Inspection and Medical Device Design Control
Jul 2015
DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions
Jul 2015
The Secrets of Successful Medical Development Process
Jun 2015
South East Asia Regulatory Compliance for Life Science Products, Live Webinar
Jun 2015
Failure Mode & Effects Analysis for Design Improvement & Control for Medical Devices, Live Webinar
Jun 2015
Designing Medical Device Alarms to Mitigate New FDA Concerns
Jun 2015
How to Develop PAT Approach-Regulatory Compliance
Jun 2015
A CAPA Primer - Elements of a CAPA Program
Jun 2015
International Product Registration: What documents are required?
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
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
The FDA Inspection: Preparation, Management, and Follow-Up
May 2015
Establish and Maintain an Effective Supplier Qualification Program
May 2015
Developing and Using the Product Risk Management File/Report
May 2015
CAPA, Failure Investigation and Root Cause Analysis - FDA Expectations
May 2015
Practical Application of HIPAA Risk Analysis
May 2015
Managing FDA After a Bad Inspection
May 2015
Design History File (DHF), Device Master Record (DMR) and DHR Utilizing the Principles of Lean Documents and Lean Configuration
May 2015
Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements
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
DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions
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
Implementing an FDA-Compliant Medical Device Design Control Including DHF, DHR, and DMR
May 2015
FDA Guidance on RUO (Research Use Only)/IUO (Investigational Use Only) Products
May 2015
What Device Firms Should Know about Design Control for an Adequate Implementation
May 2015
MDRs - Bureaucracy or Benefit
Apr 2015
ICH Q10 - Reading the Crystal Ball How will the Pharmaceutical Quality System impact the cGMPs
Apr 2015
HIPAA Audit Program Update
Apr 2015
UDI Implementation
Apr 2015
Change Control - Key to Successful cGMP Compliance
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
Quality System Regulations for Devicemakers: A Regulatory Approach
Apr 2015
Medical Packaging Validation Strategies, Planning for Success
Apr 2015
cGMPs in the Quality Control Laboratory
Apr 2015
Writing and Implementing Statistical Analysis Plans (SAPs) - Domestic and International Guidance under ICH E9
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
How to Achieve 510(k) Application Success for Device Software: Avoid Pitfalls that Could Delay Your Market Entry
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
HIPAA and BYOD - Portable Devices and Enforcement
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
Medical Device Product Development Process
Mar 2015
Avoid Warning Letters in View of the U.S. FDA`s Stated Goal
Mar 2015
Newest Developments in Medical Diagnostics & Therapy for All Health Professionals
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
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
Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials
Feb 2015
Clinical Trial Liability Lawsuits
Feb 2015
Blinding of Investigational Materials
Feb 2015
The FDA Medical Device Approval Process: Preparation of 510(k)s, IDEs, PMAs
Feb 2015
The FDA 510(k) and Q-Submission: Best Practices
Feb 2015
FDA proposed changes to ISO 13485: and Medical Devices Quality Management Systems
Jan 2015
Benchmark for Cleaning Validation
Jan 2015
EU Clinical Trial Regulation: New Requirements
Jan 2015
U.S. FDA`s Strategic Priorities - and Beyond
Jan 2015
Device Corrections and Removals
Dec 2014
Developing an Efficient Relationship with FDA
Dec 2014
Managing Product Recalls in Accordance with Part 806
Dec 2014
Special Considerations during Medical Device Design: Dos and Don`ts
Nov 2014
How to Develop an Effective Compliance Program
Oct 2014
ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements
Oct 2014
Points of Consideration during Medical Device Design and Development - Dos and Donts
Oct 2014
Legacy System Replacement in an FDA-Regulated Environment
Oct 2014
Anticipation and Expectations of a Medical OEM Design Control Audit
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
Human Factors Engineering
Sep 2014
FDA Regulations for Food, Drugs, Biologics, Cosmetics, and Medical Devices Including IVDs
Sep 2014
Current Good Manufacturing Practices (cGMP) for Medical Devices and IVDs
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
Auditing, Qualifying and Controlling, Suppliers and Contractors for Pharmaceuticals and Medical Devices (Purchasing Controls)
Jul 2014
FDA’s Part 11 – Enforcement Trends and Affordable Steps to Take Today
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
Risk Analysis: How to Do it Right under HIPAA and HITECH
Jul 2014
Integrating Risk Management into the CAPA System
Jul 2014
To file or not to file an NDA Application: When GCP Noncompliance Compromises your Pivotal Trial
Jul 2014
FDA Guidance: Medical Device Recalls
Jul 2014
FDA Guidance Design Considerations for Pivotal Clinical Investigations for Medical Devices
Jul 2014
The 510(k): Its Purpose, Compilation, and Submission
Jul 2014
Creating a value-added Internal Auditing system
Jun 2014
Best Practices With Submissions Under Medical Device User Fee Act (MDUFA)
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
Medical Device Reporting (MDR)
May 2014
Testing Medical Devices for Efficiency and Efficacy
May 2014
Implementing a Medical Device Reporting (MDR) System Integrated with a UDI System
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
Implementing a Unique Device Identification (UDI) System - Issued on 2013
Apr 2014
Adverse Event Reporting Compliance:The Key to Safe Drug Development / Subject Safety
Apr 2014
Design Change Analysis – Four Considerations
Apr 2014
The U.S. FDA`s CAPA
Apr 2014
Transferring Medical Device Production to a Contract Manufacturer - Decision Making Process and Procedures
Apr 2014
Establishing an Internal Audit Program of the Quality Management Systems Pursuant to ISO 13485 and 21 CFR Part 820
Apr 2014
Best Practices for Implementing an Adverse Event Reporting System for Medical Devices Including IVDs
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
Medical Device Changes and the 510(k)
Feb 2014
RoHS2 Compliance for Medical Devices
Feb 2014
Good Documentation Practices for Clinical Trials
Feb 2014
Effective Root Cause Analysis: The key to an effective corrective actions system
Jan 2014
Understanding Crucial Issues in the 510(k) Process
Jan 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
Clinical Trial Design for Personalised Medicine Webinar
Nov 2013
Medical Device Change(s), Analysis and 510(k) Impact
Nov 2013
Bringing Compliance To Design Control For Older Products
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
Robust Corrective And Preventive Action (CAPA)
Nov 2013
Supplier Quality Agreements for Medical Devices
Nov 2013
Corrective and Preventive Actions(CAPA) - 8 Steps to Achieve Compliance
Nov 2013
510(k) for IVDs
Nov 2013
Unique Device Identification (UDI) Final Rules Overview
Nov 2013
Thorough and Complete Investigations and Follow-up - A Current Regulatory Expectation
Oct 2013
Process Capability Indices in Medical Device Manufacturing
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
Risk Management for Medical Devices: ISO 14971:2007
Oct 2013
FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes
Aug 2013
Coping with a Difficult Compliance Officer when Responding to a 483, Warning Letter, Import Alert or Recall
Aug 2013
Regulatory Differences Between Biopharmaceutics and Medical Devices
Aug 2013
How to Manage a Medical Device Recall Efficiently and Effectively
Jul 2013
Construct and Manage the Technical File and Design Dossier
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
FDA Warning Letter Closeout Program
May 2013
Complaint Systems – The Essential Requirements
May 2013
Software Verification and Validation Planning to Meet FDA Requirements
Apr 2013
Interactive Response Technologies for Clinical Trials
Apr 2013
Overview of Combination Product Development for Pulmonary Drug Delivery
Apr 2013
Best Practices for Preparation for, Behavior during, and Response to an FDA Inspection
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
Auditing the QC Microbiology Laboratory for FDA Compliance
Apr 2013
Key Factors to develop an effective CAPA system
Apr 2013
When is Corrective Action Not Enough - Doing and Documenting Corrections is an ISO 13485 Expectation
Apr 2013
3-hr Virtual Seminar: Annual ICH GCP Refresher Course
Apr 2013
FDA Inspections - How Investigators Typically Process the Results
Apr 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
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
Best Practices in Document Approval, Control, and Distribution
Mar 2013
Electronic Records & Electronic Signatures; 21 CFR Part 11
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
Design Controls - Requirements for Medical Device Developers
Mar 2013
Risk Assessment - Compliance Using Easy To Fill Out Documentation
Mar 2013
The 510(k) Submission: Requirements, Contents, and Options
Mar 2013
Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems
Mar 2013
FDA Warning Letters - Stop Fumbling your Response and Effectively Demonstrate Compliance
Mar 2013
You have a Sterility Failure or Bioburden Excursion - Now What?
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
Ensure Compliance to FDA`s Design Control Requirements by using Requirements Management Techniques
Feb 2013
Risk-based Software Validation for Quality System software and Medical Device Data Systems (MDDS)
Feb 2013
Medicaid Drug Rebate Program (MDRP): A Primer
Feb 2013
Clinical Study Enrollment Metrics and Their Financial Impacts
Feb 2013
ISO 13485 - Medical Devices: Quality Management Systems
Feb 2013
Purchasing and Supplier Controls in the Medical Device Industry
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
Using Statistics to Determine Sample Size
Feb 2013
Root Cause Analysis
Feb 2013
Adaptive Clinical Trials - Clinical Trials Version 2.0
Feb 2013
How to Achieve CMDCAS Certification (For Medical Device Companies That Want to Sell in Canada)
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
Conformance of Design History Files for Mature Medical Products
Feb 2013
Investigator Initiated Trials - What Are We Doing to Ensure Human Subject Protection?
Feb 2013
Training on Current ICH GCP Guidelines
Feb 2013
(Medical Claim) Modifiers: Complying with Payer Variations
Feb 2013
Social Media: Using The Legal Guideposts to Create Social Media Success (for Healthcare/Lifescience Companies)
Feb 2013
Current Good Manufacturing Practice for Medical Devices Including IVDs
Jan 2013
Optimal Clinical Supply Planning for Global Drug Development
Jan 2013
Essentials of Sterilizing Grade Filter Validation
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
How to Obtain a Canadian Medical Device License
Jan 2013
Patient Reported Outcomes (PROs): Overview and Guidance for clinical trials and medical product labeling
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
Root Cause Analysis and Documentation Requirements for CAPA
Dec 2012
Change Control - Key to Successful cGMP Compliance
Dec 2012
21 CFR Part 11: Auditing for Part 11 Compliance
Dec 2012
Managing Your Medical Device Reporting (MDR)Program for Compliance Success
Nov 2012
Product Hazard Analysis and Risk Management Under ISO 14971 and FDA, ICH Q9
Nov 2012
Process Validation for Medical Devices
Nov 2012
Design Control for Medical Devices
Nov 2012
Aspects to Consider for Clean Room Qualification and Operation
Nov 2012
Bullet-Proof CAPA - Webinar By GlobalCompliancePanel
Oct 2012
How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
Oct 2012
Computer Systems Used in Clinical Trials
Oct 2012
Reprocessing REUSABLE Medical Devices - Cleaning & Labeling Requirements
Oct 2012
Avoiding 483 Observations and Warning Letters
Oct 2012
Mobile Medical Applications for Devices: Trends, Bills and Guidance
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
Post Market Surveillance for Medical Devices
Sep 2012
21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection
Sep 2012
Hazard Analysis – A practical guide
Sep 2012
Risk Assessment-Compliance Using Easy To Fill Out Documentation
Sep 2012
Medical Device Adverse Event Reporting Systems in EU, Canada and US - Webinar By GlobalCompliancePanel
Aug 2012
Key Concepts in Successful Water System Sanitization - Webinar By GlobalCompliancePanel
Aug 2012
Project Management for Computer Systems Validation - Webinar By GlobalCompliancePanel
Aug 2012
Validation and Use of Excel Spreadsheets in Regulated Environments - Webinar By GlobalCompliancePanel
Aug 2012
Site Challenges in Conducting Investigational Device Trials
Aug 2012
Management Controls Under QSR and ISO 13485 - Webinar By GlobalCompliancePanel
Aug 2012
FDA Guidelines on in Class in Man Compounds Targeting Tumor Bioenergetics from Lab Bench to Clinical Trials - Webinar By GlobalCompliancePanel
Aug 2012
Navigating the 510(k), IDE and PMA Submission and Approval Process - Webinar By GlobalCompliancePanel
Aug 2012
Human Behavior in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel
Aug 2012
Design Controls For FDA regulated industry
Aug 2012
Bullet Proof 510(k) - Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel
Aug 2012
Hazard Analysis vs. FMECA – Differences and Commonalities - Webinar By GlobalCompliancePanel
Aug 2012
CE Marking for Medical Devices Including In Vitro Diagnostic Devices - Webinar By GlobalCompliancePanel
Aug 2012
Common Problems with Software Validation Processes - Webinar By GlobalCompliancePanel
Aug 2012
Validating Excel and Word - Webinar By GlobalCompliancePanel
Aug 2012
Avoiding 483 Warning Letters & Remediation if you get one - Webinar By GlobalCompliancePanel
Aug 2012
GMP for Phase 1 Products - Webinar By GlobalCompliancePanel
Aug 2012
Implementing a Quality Systems-Based Approach to GCP Compliance - Webinar By GlobalCompliancePanel
Aug 2012
Sterilization as a Benchmark for Cleaning Validation and Control - Webinar By GlobalCompliancePanel
Aug 2012
FDA Guidance Regarding Software Validation for Clinical Trial Management Systems - Webinar By GlobalCompliancePanel
Aug 2012
Regulatory Complaint Handling, MDR`s & Recalls - Webinar By GlobalCompliancePanel
Aug 2012
Common Sense Water System Validation - Webinar By GlobalCompliancePanel
Aug 2012
The Use and Mis-use of FMEA in Medical Device Risk Management
Jul 2012
Ethics and Scientific Misconduct in Regulated Studies
Jul 2012
Software V&V Protocols and Documentation - Webinar By GlobalCompliancePanel
Jul 2012
Software validation and 21 CFR Part 11 remediation planning: FDA inspection strategies
Jul 2012
Avoiding Statistical Pitfalls during Method Validation - Webinar By GlobalCompliancePanel
Jul 2012
Auditing an Active Pharmaceutical Ingredient (API) Contract Manufacturing Organization (CMO) - Webinar By GlobalCompliancePanel
Jul 2012
IEC 62304 for Medical Device Software Development: Steps to Compliance - Webinar By GlobalCompliancePanel
Jul 2012
How to Prepare for a Tag Along Audit of CFR 21 Part 11 - Webinar By GlobalCompliancePanel
Jul 2012
The U.S. FDA`s Tougher Supplier Controls - Webinar By GlobalCompliancePanel
Jul 2012
Update On and Look Ahead At FDA’s Changes to the 510(k) Process
Jul 2012
The Drug Development Process - From R&D to Commercialization - Webinar By GlobalCompliancePanel
Jul 2012
Risk Management for Medical Devices - Webinar By GlobalCompliancePanel
Jul 2012
Good Pharmacovigilance Practice - Inspection and Audits - Webinar By GlobalCompliancePanel
Jul 2012
How to Bullet Proof your Documents from Most Commonly Cited GDP Violations - Webinar By GlobalCompliancePanel
Jul 2012
Best Practices for Medical Device Reporting (MDR), Recall, Reports of Corrections and Removals
Jul 2012
cGMPs for Medical Devices, Including In Vitro Diagnostic Devices
Jun 2012
Prepare for Tougher cGMP Compliance Audits - Webinar By GlobalCompliancePanel
Jun 2012
Medical Device Supplier Quality Agreements - Webinar By GlobalCompliancePanel
Jun 2012
The U.S. FDA`s New Global Engagement Initiative - Webinar By ComplianceOnline
Jun 2012
Medical Device: Risk Assessment and Mitigation through FMEA - Webinar By ComplianceOnline
Jun 2012
Understanding Costs of a Study for Clinical Trials - Webinar By ComplianceOnline
Jun 2012
Practical Issues with Conducting Multi-National Clinical Trials for Medical Device Approval in the US
Jun 2012
Medical Device Postmarketing Vigilance Reporting: Update and Expectations for Manufacturers - Webinar By GlobalCompliancePanel
Jun 2012
Residual Moisture Testing of Lyophilized Products - Webinar By GlobalCompliancePanel
Jun 2012
Effective Corrective and Preventive Actions (CAPA): 10 Steps - Webinar By GlobalCompliancePanel
Jun 2012
Unsolicited Drug and Device Off-Label Claims Via Social Media and Risk Management
Jun 2012
Verification and Validation (V&V) of Software in the Medical Devices - Webinar By ComplianceOnline
Jun 2012
Lean-Agile Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel
Jun 2012
Implementing Management Responsibility for Medical Devices - Webinar By GlobalCompliancePanel
Jun 2012
The 21 Elements of a 510(k) - Webinar By ComplianceOnline
Jun 2012
Leadership in Manufacturing Contamination Control - Webinar By GlobalCompliancePanel
Jun 2012
Device Corrections and Removals
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
An Overview of Risk Management and Risk Analysis Techniques in Clinical Trials
May 2012
Validation of Analytical Methods for FDA Compliance: Step-by-Step - Webinar By GlobalCompliancePanel
May 2012
Supplier Controls to Meet Tougher U.S. FDA Requirements
May 2012
Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel
May 2012
Medical Device Complaints, MDR’s and Recalls
May 2012
FDA Concerns on Alarm Standards and Safety
May 2012
Efficient Computer System Validation - 10 Easy Steps - Webinar By GlobalCompliancePanel
May 2012
Equipment Calibration in FDA QSR – Regulations and Warning Letters
May 2012
Device Changes and the 510(k) - Webinar By GlobalCompliancePanel
May 2012
Proper Documentation of Risk Management for Compliance with ISO 14971 - Webinar By GlobalCompliancePanel
May 2012
Medical Device Process Validation - Statistical Aspects - Webinar By GlobalCompliancePanel
May 2012
Applying GMP Quality Principles To Establish A Reduced Testing Program
May 2012
South Korea: Navigating the Clinical Trial and Regulatory Environment - Webinar By GlobalCompliancePanel
May 2012
Physician Payment Sunshine Act and State Sunshine Law Compliance. Are you Prepared for the New Federal Requirements and Existing State Requirements?
Apr 2012
How to Survive FDA`s `New` Inspection and Enforcement Practices
Apr 2012
Lean Project Management For U.S. FDA-Regulated Industries
Apr 2012
FDA Medical Device Regulation for the Beginner
Apr 2012
Off Label Product Use Discussions in Social Media
Apr 2012
Issue Detection and Escalation in Clinical Trial Settings
Apr 2012
How to Establish A Medical Device Quality System
Apr 2012
Validation and Use of Excel Spreadsheets in Regulated Environments
Apr 2012
Medical Device Risk Management Using ISO 14971
Mar 2012
Master Verification & Validation Planning under U.S. FDA CGMP, ICH Q-series and ISO 13485-14971 Requirements - Webinar By GlobalCompliancePanel
Mar 2012
Best Practices for Maintaining an IND and IDE Application with FDA
Mar 2012
Live webinar on Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina) By Compliance2go
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
Auditing Computer Systems for FDA and International Compliance - Webinar By GlobalCompliancePanel
Mar 2012
Changes in the EU Medical Device Directives; 2010 Modifications and the Recast of the MDD Directives - Webinar By GlobalCompliancePanel
Mar 2012
FDA`s Rules for Financial Disclosure in Clinical Trials Clarified: New Guidance, Practical Application
Mar 2012
How to Develop, Monitor and Effectively Communicate your Risk Control Strategy - Webinar By GlobalCompliancePanel
Mar 2012
Audit/Inspection Preparedness for Clinical Research/Site Coordinators
Mar 2012
Software Verification and Validation Planning and Implementation
Mar 2012
Medical Device Adverse Event Reporting and Vigilance System During Clinical Trials and Post-Marketing: US, EU, and Canada
Mar 2012
Advanced Methods of Root Causes Analysis for ISO 14971 Risk Reduction
Mar 2012
DMR & DHR - What Is Really Required
Feb 2012
Implement a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel
Feb 2012
Design History Files, Device Master Records, Device History Records, and Technical Files / Design Dossiers -- Differences and Similarities
Feb 2012
Medical Device Process Validation - Statistical Considerations
Feb 2012
Product Risk Management Under ISO 14971 and FDA-ICH Q9 - Webinar By GlobalCompliancePanel
Feb 2012
Live Web Seminar Dietary Supplement Regulatory Compliance in the United States: Labeling, Product Claims & Updates from the FDA By compliance2go
Feb 2012
Introduction to the Electronic Common Technical Document
Jan 2012
Preparing for FDA GCP Inspections – Essentials for Sponsor Companies
Jan 2012
The Evolving State of U.S. Sanctions Against Iran
Jan 2012
Validation and use of Access Databases in FDA regulated environments
Jan 2012
Live Web Seminar Design Controls: What to know when it comes to FDA regulated industry? By compliance2go
Jan 2012
Application of CAPA in (Device) Sterilization – For the Non-Expert
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
Production and QMS Software Validation - An Excel Example
Jan 2012
How to Format Succinct and Comprehensive 510(k)s and PMAs
Jan 2012
Introduction to FDA Good Documentation Practices
Jan 2012
How Doctors of Chiropractic can Bill Medicare For Durable Medical Equipment and Stay Legally Compliant
Jan 2012
Live Web Seminar China: Compliance Processes for Life Science Products (Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations By compliance2go
Jan 2012
Medical Design & Manufacturing (MD&M Online)
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LIve Webinar on ISO14000: Environmental Management - Ins and Outs of Implementation and Understanding by Compliance2go
Dec 2011
Proven Root Cause Investigation Techniques for Pharmaceutical Water Systems
Dec 2011
Live webcast on HOW TO MANAGE COMPLAINT FILES by Compliance2go
Dec 2011
Preventing Device Maintenance Related Recalls
Dec 2011
GMP Annual Training
Dec 2011
Draft Guidance for Device Industry and FDA - Postmarket Surveillance
Dec 2011
Live webinar on Excel Spreadsheet Compliance with 21 CFR 11 by Compliance2go
Dec 2011
How To Bill Medicare For Durable Medical Equipment and Stay Legally Compliant
Dec 2011
Live webinar on The 510(k) Submission Process By Compliance2go
Dec 2011
Live webinar on Applying GMP Quality Principles To a Startup a Medical Products Manufacturing Facility From Scratch By Compliance2go
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Pharmaceutical and Medical Device Good Manufacturing Practices - Similarities and Differences - Webinar By GlobalCompliancePanel
Nov 2011
Live webinar on Management of Customer Complaints: Receipt, Investigation, and Trending By Compliance2go
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Live webinar on HOW TO PERFORM PROCESS VALIDATION by Compliance2go
Nov 2011
Live webinar on New Changes to HIPAA Rules - Their expected impact and enforcement schedule By Compliance2go
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Lyophilization Process Development and Cycle Design
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
Live webinar on Design Controls: What to know when it comes to FDA regulated industry 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
Draft Guidance for Device Industry and FDA - Postmarket Surveillance - Webinar By GlobalCompliancePanel
Oct 2011
Equipment Validation, Tracking, Calibration, and Preventive Maintenance - Webinar By GlobalCompliancePanel
Oct 2011
Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel
Oct 2011
Does your Equipment Program Meet Current Regulatory Expectations - 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
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
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
Understanding Risk Management in Medical Devices
Sep 2011
FDA Validation Requirements - Webinar By ComplianceOnline
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
Reliability Engineering Fundamentals for Medical Devices - Webinar By ComplianceOnline
Sep 2011
Ensuring Integrity and Security of Laboratory Data
Sep 2011
How to design A CAPA System that meets Compliance Requirements
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
Master Validation Planning
Aug 2011
Design, Planning and Conducting Effective Audits
Aug 2011
Effective Hazard Analysis to meet FDA and ISO13485:2003 Risk Management Requirements
Aug 2011
Device Master Record & Device History Record
Aug 2011
Design History File (DHF) Device Master Record (DMR) Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained
Aug 2011
Preparing for an FDA Pre-Approval Inspection - Webinar By ComplianceOnline
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
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
ISO 13485 and medical device quality systems - practical strategies for planning, implementation and beyond
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
Clinical Project Management - Webinar By ComplianceOnline
Aug 2011
Design History Files, Device Master Records, Device History Records, and Technical Files / Design Dossiers
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
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
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
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
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
3hr Virtual Seminar on Designing Medical Devices for Patient Safety
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
Develop and Execute the Company Software V&V Program - Webinar By GlobalCompliancePanel
Jun 2011
Risk-Based Validation for GxP Facilities - Webinar By GlobalCompliancePanel
Jun 2011
Pharmaceutical and Medical Device Validation Guidance`s - Similarities and Differences - Webinar By GlobalCompliancePanel
May 2011
`The Right Stuff` – Implementing Quality Control Tools in Quality Systems Operations
May 2011
Sterilization Options for Challenging Products
May 2011
The GCP/ICH Obligations of Sponsors, Monitors, and Investigators - barriers and solution - Webinar By GlobalCompliancePanel
May 2011
Designing a CAPA System that Meets and Exceeds Regulatory Requirements - Webinar By GlobalCompliancePanel
May 2011
Retirement of Computer Systems: Strategies for FDA Compliance and Tools for Implementation
May 2011
FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP
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
Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel
May 2011
Best Practices for the Implementation and Use of Test Management Tools - Webinar By GlobalCompliancePanel
Apr 2011
Gowning Systems Used in Cleanrooms & Controlled Environments - Webinar By GlobalCompliancePanel
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 FDA’s final Medical Device Data System (MDDS) rule and its implications for currently regulated and unregulated vendors and providers
Apr 2011
How to successfully create a Device History Record and keep FDA happy in the process - Webinar By GlobalCompliancePanel
Apr 2011
Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements - ComplianceOnline Medical Device Training
Apr 2011
Process Validation for Medical Device Manufacturers
Apr 2011
Preparing for Pre-approval Inspections - Webinar By GlobalCompliancePanel
Apr 2011
Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel
Apr 2011
The 510(k) Process and Risk Management
Apr 2011
Data Security Analysis for Healthcare Providers - Webinar By GlobalCompliancePanel
Apr 2011
FDA`s Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List - Webinar By GlobalCompliancePanel
Apr 2011
Understanding Attribute Acceptance Sampling including Z1.4 and c=0 Plans - Webinar By GlobalCompliancePanel
Apr 2011
Elements of the Lot Disposition Process - Webinar By GlobalCompliancePanel
Apr 2011
FDA`s Revised 510(k) Premarket Notification Process
Apr 2011
Decoding CLIA Regulations: Calibration, Calibration Verification and Method Validation
Apr 2011
The Use and Mis-use of FMEA in Medical Device Risk Management - Webinar By GlobalCompliancePanel
Apr 2011
Change Control -- Your Company`s GMP Weak Point - Webinar By GlobalCompliancePanel
Apr 2011
Controlled Substances and the Hospital Pharmacy - Webinar By GlobalCompliancePanel
Apr 2011
Understanding the Calibration Curve - Webinar By GlobalCompliancePanel
Mar 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
Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel
Mar 2011
Medical Device Recalls: How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel
Mar 2011
How to use QSIT to Your Advantage - Webinar By GlobalCompliancePanel
Mar 2011
Off-Label Promotion of Drugs - Regulatory Documents Explained - Webinar By GlobalCompliancePanel
Mar 2011
Process Validation: current industry practices and FDA Guidance Document Review - Webinar by GlobalCompliancePanel
Mar 2011
Recruiting is Critical to Your Success: What is the Secret - Webinar By GlobalCompliancePanel
Mar 2011
Project Management for Clinical Trials - Webinar By GlobalCompliancePanel
Mar 2011
The Investigation System (Discovery, Planning, Root Cause Analysis, CAPA) - Webinar By GlobalCompliancePanel
Mar 2011
Food Drug & Cosmetic Act: Implementing Regulations & Major New Laws - An Overview - Webinar By GlobalCompliancePanel
Mar 2011
Why is CAPA so often cited in medical device inspections - Webinar By GlobalCompliancePanel
Feb 2011
Software Verification and Validation Planning and Execution
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
Electronic Raw Data in Regulated Environments - Definition, Recording and Archiving - Webinar By GobalCompliancePanel
Feb 2011
Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel
Feb 2011
Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel
Feb 2011
Don`t RISK to ignore RISKS. Understanding ISO 14971
Feb 2011
CE Marking: Obtaining and Maintaining EU Compliance Under the Medical Device Directive 2010
Feb 2011
Full Day Virtual Seminar : Process Validation for Medical Devices - FDA Inspectors are Checking – Are You Prepared?
Feb 2011
Webinar on Medical Device Tracking
Feb 2011
Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel
Feb 2011
Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By GlobalCompliancePanel
Feb 2011
Risk-Based Verification and Validation Planning to Meet U.S. FDA, ICH Q9 and ISO 14971
Feb 2011
Analytical Instrument and Equipment Qualification in Quality Laboratories - Webinar By GlobalCompliancePanel
Feb 2011
Medical Device Complaints Handling Strategies for Managing Your Biggest Compliance Challenge
Jan 2011
Webinar on Pharmacovigilance Audit - Webinar By GlobalCompliancePanel
Jan 2011
Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel
Jan 2011
Full day Virtual Seminar - Compliance for 21 CFR Part 11, reducing costs using risk-based computer system validation
Jan 2011
Assessing FDA’s Proposed Changes to the 510(k) Process in
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
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
101 cGMP To-Do List for - Webinar By GlobalCompliancePanel
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
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
Recalls of Medical Devices in the US
Dec 2010
Updated EU filing and registration procedures (including the new variation rules coming in to force) - ComplianceOnline Medical Device Training
Nov 2010
EU Medical Device Changing Regulatory Landscape; Changes Now and What Current Re-writes Hold for 2011-12 - ComplianceOnline Medical Device Training
Nov 2010
Full Day Virtual Seminar - Reduce Software Validation Costs and Pass the New 21 CFR Part 11 Inspections - by GlobalCompliancePanel
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
Equipment Calibration, Maintenance, and Validation: What Auditors Look for in a Controlled Process
Nov 2010
Q4 EMT (Emerging Medical Technologies) Spotlight
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
Full Day Virtual Seminar - Design and Validation of Excel Spreadsheets: Step-by-Step
Oct 2010
The Most Common Problems in FDA Software Validation & Verification - Webinar by GlobalCompliancePanel
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
The Tougher U.S. FDA - One Year Later
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
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
Integrating Clinical Evaluation and Risk Management (ISO 14971)
Oct 2010
Best Practices for Writing an Effective SOP to Lead to Successful FDA Inspections
Oct 2010
Development, Management, and Operation of an Effective Supplier and Internal Auditing System - Webinar by GlobalCompliancePanel
Sep 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
Validating Radiation Sterilization for medical device industries
Sep 2010
Robust Process Validation for Medical Devices - Webinar by GlobalCompliancePanel
Sep 2010
Understanding and Preparing for FDA`s New Part 11 Inspection Program
Sep 2010
Effective Quality Process Improvement for Medical Device Firms: Don’t get caught managing process through standardized SOP’s
Sep 2010
Compiling the Design History File, and Technical File / Design Dossier - Webinar by GlobalCompliancePanel
Sep 2010
The ICF Process: Tips on Achieving Optimal compliance and Comprehension
Sep 2010
Developing Supplier Quality Auditor Training Programs
Sep 2010
Medical Devices in the EU: CE Mark and 93/42/EEC Directive
Sep 2010
Developing an ethylene oxide (EO) sterilization process for a product with limitations
Sep 2010
Understanding Acceptance Activities for Medical Devices - Webinar by GlobalCompliancePanel
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
Post-Design Medical Device Risk Management - Webinar by GlobalCompliancePanel
Sep 2010
Understanding Corrective and Preventive Action, and Elements of a CAPA System - Webinar by GlobalCompliancePanel
Sep 2010
Product Risk Management - ISO 14971 and ICH Q9
Aug 2010
Conducting Value Added Audits of Technical Service Providers - Webinar by GlobalCompliancepanel
Aug 2010
Understanding International Standards for Medical Devices
Aug 2010
Regulatory Requirements for Medical Device Calibration Programs - Webinar by GlobalCompliancepanel
Aug 2010
Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements - Webinar by GlobalCompliancepanel
Aug 2010
Important Sterilization Information for Product Developers - Webinar by GlobalCompliancePanel
Aug 2010
Failure Modes and Effects Analysis (FMEA) - An Effective Tool for Medical Device Risk Management - Webinar by GlobalCompliancePanel
Aug 2010

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