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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

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

Functional and System Requirements for Systems Regulated by FDA in 2024

Functional and System Requirements for Systems Regulated by FDA in 2024

Overview: The validation of computer systems (CSV) under FDA regulations has shaped the way e..

Date : 25th November 2024

Time : This Event is Over and the Recorded Content is Available

Duration : 90 Mins

Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

10 Minutes excerpt from the recorded event for your review:Read the LinkedIn Article: LinkedIn ..

Date : 30th May 2024

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

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

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