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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
Audit Trail Review by Exception in FDA-Regulated Environments: Reducing Review Burden While Strengthening Data Integrity
Overview Audit trails are essential to maintaining trustworthy electronic records in FDA-regu..
Date : 28th August 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
AI in Drug Development: FDA Compliance, Validation, and Data Integrity
Overview: Artificial Intelligence is no longer sitting at the edge of drug development. It is ..
Date : 24th June 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Best Practices for FDA Computer System Audit Preparation in 2026
Overview: For those of us who have worked around FDA-regulated computer systems for many year..
Date : 29th May 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Medical Device Cybersecurity Following FDA’s 2026 Premarket Guidance
Overview Cybersecurity is now a central part of FDA’s review expectations for many connected, ..
Date : 28th May 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
The 6 Most Common Problems in FDA Software Validation and Verification in 2026
Overview: Software validation and verification remain common sources of compliance risk for F..
Date : 14th May 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
FDA’s Q-Submission Program for Medical Devices, Software-in-a-Medical Device Products & SaMD with Considerations for Using AI & ChatGPT
Overview: The U.S. Food and Drug Administration (FDA) has taken a major step toward modernizi..
Date : 22nd October 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Preparing a FDA 510(k) submission - What to Know in 2025
Overview: The FDA 510(k) submission process remains one of the most crucial regulatory pathwa..
Date : 26th June 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
The 6 Most Common Problems in FDA Software Validation and Verification in 2025
Overview: Professionals working with FDA-regulated software face numerous challenges when it co..
Date : 12th June 2025
Time : This Event is Over
Duration : 75 Mins
FDA Regulation of Artificial Intelligence/ Machine Learning Software following the 2025 draft Guidance
Overview: AI/ML is rapidly transforming the landscape of medicine, driving unprecedented chan..
Date : March 28, 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR in 2025
Overview: In today's rapidly evolving life sciences landscape, ensuring data integrity and priv..
Date : 14th February 2025
Time : This Event is Over
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
Preparing a FDA 510(k) submission - What to Know in 2024
Overview: The FDA 510(k) submission process remains one of the most crucial regulatory pathwa..
Date : 29th October 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins