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21 CFR Part 11 & Data Integrity 2026: CSA, Cloud, AI & Annex 11
OverviewA Part 11 problem rarely begins with someone deliberately ignoring a regulation. More ofte..
Date : 23rd September 2026
Time : This Event is Over
Duration : 75 Mins
Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR in 2026
Overview: In 2026, data integrity and privacy risks don’t sit in one department—they show up ..
Date : 19th March 2026
Time : This Event is Over
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 : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
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
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
Responding to FDA Form 483 Observations: What FDA Expects in 2026
Overview: Receiving a Form FDA 483 at the conclusion of an inspection can put an organization ..
Date : 28th October 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 Mins
The 6 Most Common FDA Software Validation Failures and How to Prevent Them
Overview: One of the most concerning findings during an FDA inspection is discovering that an ..
Date : 10th November 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 75 Mins