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Risk-Based Excel Spreadsheet Validation and FDA Compliance - Risk-Based CSV/CSA & Part 11
Overview:FDA inspections and audits continue to put a bright spotlight on data integrity—especiall..
Date : 27th January 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
An Advanced Course on Lean Documents, Lean Configuration, and Document Control - What to Know
Overview: In today’s life sciences environment, document control is often where “lean” quietl..
Date : 26th January 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
FDA’s QMSR is Coming: Practical Readiness for Quality Teams
Overview: With the FDA’s Quality Management System Regulation (QMSR) taking effect in February..
Date : 21st January 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
Transition from CSV to CSA; FDA Final CSA Guidance, September 2025 for Medical Device Manufacturing & Quality Testing
Overview: For decades, life-science teams have relied on Computer System Validation (CSV)—sha..
Date : 21st November 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Excel Spreadsheet in FDA Regulated Environment - Validating Excel for GxP & 21 CFR Part 11
Overview: The use of Excel in FDA-regulated environments goes far beyond basic analysis. When ..
Date : 21st November 2025
Time : This Event is Over
Duration : 75 Mins
Project Management for CSV in FDA-Regulated Environments (CSA, GAMP®5 2nd Ed.) — with a Brief AI/ChatGPT Overview for PM Support
Overview: Computer System Validation (CSV) has underpinned FDA compliance in regulated industr..
Date : 30th October 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
FDA’s Q-Submission Program for Medical Devices, Software-in-a-Medical Device Products & SaMD with Considerations for Using AI & ChatGPT
Overview: The U.S. Food and Drug Administration (FDA) has taken a major step toward modernizi..
Date : 22nd October 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Clinical Trial Systems: Trial Master File (TMF) and eTMF, & FDA’s Recent Draft Guidance for Electronic Records/Signatures Used in Clinical Trials
Overview: Organizations involved in the conduct of human clinical trials must meet rigorous re..
Date : 30th September 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Validation of FDA-Regulated Systems with AI, ML & LLMs (ChatGPT)
Overview: Life science industries — including pharmaceutical, medical device, biotechnology, ..
Date : 11th September 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR - 2025
Overview: In today's rapidly evolving life sciences landscape, ensuring data integrity and pr..
Date : 21st August 2025
Time : This Event is Over
Duration : 75 Mins
Best Practices in Preparation for an FDA Computer System Audit in 2025
Overview: In 2025, the FDA's expectations for validated computer systems have never been high..
Date : 31st July 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA in 2025
Overview: The U.S. Food and Drug Administration (FDA) plays a critical role in safeguarding pub..
Date : 27th June 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Preparing a FDA 510(k) submission - What to Know in 2025
Overview: The FDA 510(k) submission process remains one of the most crucial regulatory pathwa..
Date : 26th June 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
The 6 Most Common Problems in FDA Software Validation and Verification in 2025
Overview: Professionals working with FDA-regulated software face numerous challenges when it co..
Date : 12th June 2025
Time : This Event is Over
Duration : 75 Mins
Data Integrity and Data Governance for Computer Systems Regulated by FDA in 2025
Overview: As regulatory scrutiny intensifies, data integrity and governance have become corne..
Date : 30th May 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins