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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
Clinical Trial Systems: Trial Master File (TMF) and eTMF, & FDA’s Recent Draft Guidance for Electronic Records/Signatures Used in Clinical Trials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
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
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 : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 Mins