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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

Best Practices in Preparation for an FDA Computer System Audit in 2025

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

Data Integrity and Data Governance for Computer Systems Regulated by FDA in 2025

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

FDA Recent Draft Guidance Related to 21 CFR Part 11, Electronic Records/Signatures for Clinical Investigations

FDA Recent Draft Guidance Related to 21 CFR Part 11, Electronic Records/Signatures for Clinical Investigations

Overview: Companies engaged in human clinical trials must comply with specific regulatory requ..

Date : 01st February 2024

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

Duration : 90 Mins

Risk-Based Excel Spreadsheet Validation and FDA Compliance - Risk-Based CSV/CSA & Part 11

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 : 1:00 PM Eastern Time / 10:00 AM Pacific Time

Duration : 90 Mins

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