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Validation of FDA-Regulated Systems with AI, ML & LLMs (ChatGPT)

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

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

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

Mastering Mobile App & Medical Device Software Validation and Cybersecurity in FDA-Regulated Environments

Mastering Mobile App & Medical Device Software Validation and Cybersecurity in FDA-Regulated Environments

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

Date : 28th June 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

GAMP®5, 2nd Edition & FDA's CSA Guidance - Aligning Validation Practices

GAMP®5, 2nd Edition & FDA's CSA Guidance - Aligning Validation Practices

Overview The landscape of computer system validation is undergoing a transformative shift wit..

Date : 30th April 2024

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

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

Duration : 90 Mins

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