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Chronicles

By Carolyn Troiano

FDA Trends in Compliance and Enforcement in Computer Systems and Data

Date: April 8, 2025

By Edwin Waldbusser

How to Prepare For and Host a FDA Inspection and Respond to 483's

Date: April 10, 2025

By Carolyn Troiano

FDA Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data Integrity

Date: April 21, 2025

By Meredith Crabtree

From Challenges to Compliance: Understanding Dietary Supplement Oversight by the FDA

Recorded Session

By Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

Recorded Session

By David Nettleton

Excel Spreadsheets; Develop and Validate for 21 CFR Part 11 Compliance

Recorded Session

By Carolyn Troiano

FDA Compliance And Laboratory Computer System Validation

Recorded Session

By Charles H. Paul

ChatGPT and Project Management: Leveraging AI for Project Management Excellence

Recorded Session

By Rachelle D Souza

FDA Recommendations for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions

Recorded Session

By Kelly Thomas

Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers

Recorded Session

By Edwin Waldbusser

Human Factors Usability Studies Following ISO 62366 and FDA Guidance

Recorded Session

By Meredith Crabtree

SOPs - How to Write Them to Satisfy those Inspectors

Recorded Session

By David Nettleton

The 6 Most Common Problems in FDA Software Validation and Verification

Recorded Session

By Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

Recorded Session

By Ginette M. Collazo

Implementing an Effective Human Error Reduction Program

Recorded Session

By Meredith Crabtree

Performance of Root Cause Analysis, CAPA, and Effectiveness Checks

Recorded Session

By David Nettleton

2-Hour Virtual Seminar on the 6 Most Common Problems in FDA Software Validation and Verification

Recorded Session

By William A. Levinson

Zero Acceptance Sampling to Reduce Inspection Costs

Recorded Session

By Kelly Thomas

Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

Recorded Session

By Meena Chettiar

Setting up Quality System for FDA Regulated Products: Tips and Tricks for your Regulatory Compliance

Recorded Session

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

By Jeff Kasoff

Best Practices in Complaint Management for Regulatory Compliance and Customer Retention

Recorded Session

By Carolyn Troiano

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

Recorded Session

By Jeff Kasoff

Navigating FDA Inspections: From SOP to 483

Recorded Session

By Carolyn Troiano

Clinical Trial Systems: The Trial Master File (TMF) and Electronic Trial Master File (eTMF)

Recorded Session

By Jeff Kasoff

Supplier Management: Overcoming Challenges and Exploring Opportunities

Recorded Session

By Kelly Thomas

Implementing a Robust Change Control Program - Key Elements for Process and Documentation Compliance

Recorded Session

By Kelly Thomas

Writing Effective 483 and Warning Letter Responses

Recorded Session

By Carolyn Troiano

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

Recorded Session

By Kelly Thomas

Aseptic Process Validation: Top-Tips for Compliance and Success

Recorded Session

By Kelly Thomas

Analytical Method Validation and Transfer Course

Recorded Session

By Carolyn Troiano

FDA Compliance and Clinical Trial Computer System Validation

Recorded Session

By Meredith Crabtree

FDA current recommendations related to timely initiation of and responses to recalls

Recorded Session

By Ginette M. Collazo

How to implement an effective Human Error Investigation Program

Recorded Session

By Ginette M. Collazo

Supervising a Human Error Free Environment: You can do a Lot More than you Think

Recorded Session

By Kelly Thomas

FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control

Recorded Session

By Michael Esposito

Bad Standard Operating Procedures (SOPs) - Bad Training: Garbage In, Garbage Out

Recorded Session

By Carolyn Troiano

Data Governance for Computer Systems Regulated by FDA

Recorded Session

By Willi Ramseier

FDA 21 CFR Part 11

Recorded Session

By Michael Esposito

Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success

Recorded Session

By Carolyn Troiano

Data Governance for Computer Systems Regulated by FDA

Recorded Session

By Danielle DeLucy

FDA Case Scenarios - Best Practices for Managing Inspection Situations

Recorded Session

By Carolyn Troiano

Data Governance for Computer Systems Regulated by FDA

Recorded Session

By Jeff Kasoff

The FDA Inspection: Preparation, Performance and Follow-Up

Recorded Session

By Carolyn Troiano

FDAs Recent Clarification on Guidance for Managing Data Integrity for Regulated Computer Systems

Recorded Session

By Michael Esposito

Packaging and Labeling in Pharmaceutical Product Development - Best Practices

Recorded Session

By Carolyn Troiano

The 6 Most Common Problems in FDA Software Validation and Verification Computer System Validation Step-by-Step

Recorded Session

By Susanne Manz

Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

Recorded Session

By Edwin Waldbusser

21 CFR Part 11 Conformance for Medical Devices

Recorded Session

By Casper E Uldriks

FDA s New Import Program for 2019

Recorded Session

By Michael Esposito

Using Learning Management Systems (LMS) to Develop Pharma Training: Rewards & Challenges

Recorded Session

By Dr. Loren Gelber

Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations

Recorded Session

By J.Lawrence Stevens

FDA's Enforcement Strategy for Mobile Medical Applications

Recorded Session

By Dr. John Ryan holds

Food Safety And Quality In Home Food Delivery

Recorded Session

FDA Compliance

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