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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
Medical Device Hazard Analysis Under FDA QMSR: A Practical ISO 14971 Guide
OverviewHazard analysis has always played an important role in medical device safety. Under FDA’s ..
Date : 25th August 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Quality Management System Regulation (QMSR) – Replacement of QSR and Alignment with ISO
Overview: Effective February 2, 2026, FDA’s Quality Management System Regulation (QMSR) became..
Date : 23rd April 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Prepare for FDA QMSR Inspections: 483 & Warning Letter Response
Overview: FDA inspections under the new QMSR can look and feel different—not just in what inv..
Date : 23rd February 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
ISO 13485:2016 Utilizing Principles of Lean Documents and Lean Configuration
Overview: Medical device and life science organizations are expected to maintain a Quality Ma..
Date : 20th February 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
An Advanced Course on Lean Documents, Lean Configuration, and Document Control - What to Know
Overview: In today’s life sciences environment, document control is often where “lean” quietl..
Date : 26th January 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
FDA’s QMSR is Coming: Practical Readiness for Quality Teams
Overview: With the FDA’s Quality Management System Regulation (QMSR) taking effect in February..
Date : 21st January 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 60 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
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
Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR - 2025
Overview: In today's rapidly evolving life sciences landscape, ensuring data integrity and pr..
Date : 21st August 2025
Time : This Event is Over
Duration : 75 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
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 Human Factors Usability Guidance | ISO 62366 & Draft Update Explained
Overview: Human Factors/Usability studies are essential in ensuring that medical devices are ..
Date : 29th May 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Minutes