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FDA Compliance

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By David R. Dills
FDA Proposes Framework to Advance Credibility of AI Models
Date: May 21, 2025

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By Carolyn Troiano
FDA Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data Integrity
Recorded Session

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By Edwin Waldbusser
How to Prepare For and Host a FDA Inspection and Respond to 483's
Recorded Session

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By Meredith Crabtree
From Challenges to Compliance: Understanding Dietary Supplement Oversight by the FDA
Recorded Session

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By Edwin Waldbusser
FDA Regulation of Artificial Intelligence/ Machine Learning
Recorded Session

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By David Nettleton
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11 Compliance
Recorded Session

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By Carolyn Troiano
FDA Compliance And Laboratory Computer System Validation
Recorded Session

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By Charles H. Paul
ChatGPT and Project Management: Leveraging AI for Project Management Excellence
Recorded Session

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By Rachelle D Souza
FDA Recommendations for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
Recorded Session

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By Kelly Thomas
Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers
Recorded Session

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By Edwin Waldbusser
Human Factors Usability Studies Following ISO 62366 and FDA Guidance
Recorded Session

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By Meredith Crabtree
SOPs - How to Write Them to Satisfy those Inspectors
Recorded Session

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By David Nettleton
The 6 Most Common Problems in FDA Software Validation and Verification
Recorded Session

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By Edwin Waldbusser
21 CFR Part 11 - Compliance for Electronic Records and Signatures
Recorded Session

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By Ginette M. Collazo
Implementing an Effective Human Error Reduction Program
Recorded Session

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By Meredith Crabtree
Performance of Root Cause Analysis, CAPA, and Effectiveness Checks
Recorded Session

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By David Nettleton
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA Software Validation and Verification
Recorded Session

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By William A. Levinson
Zero Acceptance Sampling to Reduce Inspection Costs
Recorded Session

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By Kelly Thomas
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
Recorded Session

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By Meena Chettiar
Setting up Quality System for FDA Regulated Products: Tips and Tricks for your Regulatory Compliance
Recorded Session

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By Jeff Kasoff
Best Practices in Complaint Management for Regulatory Compliance and Customer Retention
Recorded Session

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By Meredith Crabtree
Ensuring Safe and Effective Pharmaceutical Products: A Comprehensive Guide to ICH Q9 (R1) Quality Risk Management in the Pharmaceutical Industry
Recorded Session

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By Carolyn Troiano
Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
Recorded Session

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By Jeff Kasoff
Navigating FDA Inspections: From SOP to 483
Recorded Session

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By Carolyn Troiano
Clinical Trial Systems: The Trial Master File (TMF) and Electronic Trial Master File (eTMF)
Recorded Session

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By Jeff Kasoff
Supplier Management: Overcoming Challenges and Exploring Opportunities
Recorded Session

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By Kelly Thomas
Implementing a Robust Change Control Program - Key Elements for Process and Documentation Compliance
Recorded Session

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By Kelly Thomas
Writing Effective 483 and Warning Letter Responses
Recorded Session

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By Carolyn Troiano
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
Recorded Session

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By Kelly Thomas
Aseptic Process Validation: Top-Tips for Compliance and Success
Recorded Session

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By Kelly Thomas
Analytical Method Validation and Transfer Course
Recorded Session

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By Carolyn Troiano
FDA Compliance and Clinical Trial Computer System Validation
Recorded Session

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By Meredith Crabtree
FDA current recommendations related to timely initiation of and responses to recalls
Recorded Session

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By Ginette M. Collazo
How to implement an effective Human Error Investigation Program
Recorded Session

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By Ginette M. Collazo
Supervising a Human Error Free Environment: You can do a Lot More than you Think
Recorded Session

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By Kelly Thomas
FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control
Recorded Session

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By Michael Esposito
Bad Standard Operating Procedures (SOPs) - Bad Training: Garbage In, Garbage Out
Recorded Session

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By Carolyn Troiano
Data Governance for Computer Systems Regulated by FDA
Recorded Session

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By Willi Ramseier
FDA 21 CFR Part 11
Recorded Session

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By Michael Esposito
Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success
Recorded Session

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By Carolyn Troiano
Data Governance for Computer Systems Regulated by FDA
Recorded Session

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By Danielle DeLucy
FDA Case Scenarios - Best Practices for Managing Inspection Situations
Recorded Session

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By Carolyn Troiano
Data Governance for Computer Systems Regulated by FDA
Recorded Session

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By Jeff Kasoff
The FDA Inspection: Preparation, Performance and Follow-Up
Recorded Session

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By Carolyn Troiano
FDAs Recent Clarification on Guidance for Managing Data Integrity for Regulated Computer Systems
Recorded Session

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By Michael Esposito
Packaging and Labeling in Pharmaceutical Product Development - Best Practices
Recorded Session

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By Carolyn Troiano
The 6 Most Common Problems in FDA Software Validation and Verification Computer System Validation Step-by-Step
Recorded Session

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By Susanne Manz
Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices
Recorded Session

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By Edwin Waldbusser
21 CFR Part 11 Conformance for Medical Devices
Recorded Session

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By Casper E Uldriks
FDA s New Import Program for 2019
Recorded Session

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By Michael Esposito
Using Learning Management Systems (LMS) to Develop Pharma Training: Rewards & Challenges
Recorded Session

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By Dr. Loren Gelber
Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations
Recorded Session

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By J.Lawrence Stevens
FDA's Enforcement Strategy for Mobile Medical Applications
Recorded Session

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By Dr. John Ryan holds
Food Safety And Quality In Home Food Delivery
Recorded Session

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