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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
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
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
Overview: Test Method Validation (TMV) is a critical yet often misunderstood requirement in t..
Date : 21st October 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Medical Device Software Verification and Validation Following FDA 2023 Guidance and ISO 62304
Overview: In the fast-evolving field of medical technology, ensuring the safety and efficacy ..
Date : 28th May 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
In-Depth Testing of Computer Systems Regulated by FDA - What You Need to Know?
Overview:This webinar will focus on testing as a key element of Computer System Validation (CSV). ..
Date : 28th May 2021
Time : This Event is Over and the Recorded Copy is Available
Duration : 1 Hour 24 Mins
Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program
Overview:Bacterial Endotoxin Test (BET) is a vital safety requirement in the current good manufact..
Date : 29th April 2021
Time : This Event is Over and the Recorded Copy is Available
Duration : 60 Mins
FDA Biocompatibility in 2026: What to Test, What to Justify, and What to Submit
Overview A medical device can undergo extensive biocompatibility testing and still encounter ..
Date : 16th November 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 120 Mins
FDA Medical Device Cybersecurity in 2026: SBOMs, Threat Modeling and Submission Evidence
Overview A medical device manufacturer may have a software bill of materials, a completed thr..
Date : 30th November 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 120 Mins