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FDA Compliance
Live Webinars
Chronicles
By David Nettleton
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11 Compliance
Date: Sept. 9, 2024
By Carolyn Troiano
Artificial Intelligence (AI), Machine Learning, and FDA Compliance for Computer Systems and Data
Date: Sept. 9, 2024
By Edwin Waldbusser
FDA Regulation of Artificial Intelligence/ Machine Learning
Date: Sept. 10, 2024
By Carolyn Troiano
Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
Date: Sept. 19, 2024
By Edwin Waldbusser
Human Factors Usability Studies Following ISO 62366 and FDA Guidance
Date: Sept. 23, 2024
By Meredith Crabtree
Ensuring Safe and Effective Pharmaceutical Products: A Comprehensive Guide to ICH Q9 (R1) Quality Risk Management in the Pharmaceutical Industry
Date: Sept. 23, 2024
By Jeff Kasoff
Best Practices in Complaint Management for Regulatory Compliance and Customer Retention
Date: Sept. 23, 2024
By Meena Chettiar
Setting up Quality System for FDA Regulated Products: Tips and Tricks for your Regulatory Compliance
Date: Sept. 26, 2024
By Dr. John Ryan holds
Food Safety And Quality In Home Food Delivery
Recorded Session
By J.Lawrence Stevens
FDA's Enforcement Strategy for Mobile Medical Applications
Recorded Session
By Dr. Loren Gelber
Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations
Recorded Session
By Michael Esposito
Using Learning Management Systems (LMS) to Develop Pharma Training: Rewards & Challenges
Recorded Session
By Casper E Uldriks
FDA s New Import Program for 2019
Recorded Session
By Edwin Waldbusser
21 CFR Part 11 Conformance for Medical Devices
Recorded Session
By Susanne Manz
Root Cause Analysis for CAPA - Myths, Challenges, and 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 Michael Esposito
Packaging and Labeling in Pharmaceutical Product Development - Best Practices
Recorded Session
By Carolyn Troiano
FDAs Recent Clarification on Guidance for Managing Data Integrity for Regulated Computer Systems
Recorded Session
By Jeff Kasoff
The FDA Inspection: Preparation, Performance and Follow-Up
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 Michael Esposito
Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success
Recorded Session
By Willi Ramseier
FDA 21 CFR Part 11
Recorded Session
By Carolyn Troiano
Data Governance for Computer Systems Regulated by FDA
Recorded Session
By Michael Esposito
Bad Standard Operating Procedures (SOPs) - Bad Training: Garbage In, Garbage Out
Recorded Session
By Kelly Thomas
FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control
Recorded Session
By Ginette M. Collazo
Supervising a Human Error Free Environment: You can do a Lot More than you Think
Recorded Session
By Ginette M. Collazo
How to implement an effective Human Error Investigation Program
Recorded Session
By Meredith Crabtree
FDA current recommendations related to timely initiation of and responses to recalls
Recorded Session
By Carolyn Troiano
FDA Compliance and Clinical Trial Computer System Validation
Recorded Session
By Kelly Thomas
Analytical Method Validation and Transfer Course
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
Writing Effective 483 and Warning Letter Responses
Recorded Session
By William A. Levinson
Zero Acceptance Sampling to Reduce Inspection Costs
Recorded Session
By Kelly Thomas
Implementing a Robust Change Control Program - Key Elements for Process and Documentation Compliance
Recorded Session
By Jeff Kasoff
Supplier Management: Overcoming Challenges and Exploring Opportunities
Recorded Session
By Edwin Waldbusser
21 CFR Part 11 - Compliance for Electronic Records and Signatures
Recorded Session
By Carolyn Troiano
Clinical Trial Systems: The Trial Master File (TMF) and Electronic Trial Master File (eTMF)
Recorded Session
By Kelly Thomas
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
Recorded Session
By Kelly Thomas
Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers
Recorded Session
By Edwin Waldbusser
How to Prepare For and Host a FDA Inspection and Respond to 483's
Recorded Session
By Ginette M. Collazo
Implementing an Effective Human Error Reduction Program
Recorded Session
By Jeff Kasoff
Navigating FDA Inspections: From SOP to 483
Recorded Session
By Meredith Crabtree
From Challenges to Compliance: Understanding Dietary Supplement Oversight by the FDA
Recorded Session
By Carolyn Troiano
FDA Compliance And Laboratory Computer System Validation
Recorded Session
By Carolyn Troiano
FDA Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data Integrity
Recorded Session
By Meredith Crabtree
Performance of Root Cause Analysis, CAPA, and Effectiveness Checks
Recorded Session
By Meredith Crabtree
SOPs - How to Write Them to Satisfy those Inspectors
Recorded Session
By Rachelle D Souza
FDA Recommendations for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
Recorded Session
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