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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
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
FDA Recent Draft Guidance Related to 21 CFR Part 11, Electronic Records/Signatures for Clinical Investigations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
FDA Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data Integrity
Overview: For over three decades, the FDA has regulated computer system validation in industr..
Date : 27th November 2023
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
Overview:Navigating the FDA's guidelines on computer system validation is no simple task, particul..
Date : 26th September 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins