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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
Risk-Based Approach to Validating IT Infrastructure Used for FDA-Regulated Systems
Overview: For over three decades, the FDA has regulated computer system validation (CSV) acro..
Date : 25th March 2024
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-
Overview: In today's rapidly evolving life sciences landscape, ensuring data integrity and pr..
Date : 21st March 2024
Time : This Event is Over
Duration : 90 Mins
Validation of FDA-Regulated Systems that Incorporate Artificial Intelligence (AI) and Machine Learning (ML)
Overview: As the life sciences industry, encompassing pharmaceuticals, medical devices, biote..
Date : 23rd February 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
FDA Regulation of Artificial Intelligence/ Machine Learning Software following the new draft Guidance
Overview: Artificial Intelligence (AI) and Machine Learning (ML) are fast becoming game-change..
Date : 24th October 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
510K Submission Process for Medical Devices
Overview: There are three types of 510(k) submissions that can be submitted – Traditional, Spec..
Date : 25th August 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Mastering Mobile App Validation in FDA-Regulated Environments
Overview: In this webinar, we will delve into the critical aspects of applying computer syste..
Date : 26th May 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
FDA Regulation of Artificial Intelligence/ Machine Learning - New FDA Guidance
Overview:Explore how AI/ML is transforming medicine by making diagnosis and treatment more accessibl..
Date : 27th April 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Medical Device Software Validation Meeting FDA Regulations
Overview: Testing software to prove that it works and has no bugs is not sufficient to obtain ..
Date : 25th October 2022
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
FDA Regulation of Artificial Intelligence/ Machine Learning
Overview: AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible ..
Date : 25th May 2022
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
FDA Regulation of Mobile medical apps and cybersecurity
Overview: This webinar will explain how to determine if your app is a medical device and if it..
Date : 24th August 2021
Time : This Event is Over and the Recorded Copy is Available
Duration : 60 Mins
FDA Regulation of Artificial Intelligence/ Machine Learning - What You Need to Know?
Overview: AI/ ML will revolutionize medicine by making diagnosis and treatment more accessibl..
Date : 30th June 2021
Time : This Event is Over and the Recorded Copy 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
Data Integrity and Governance for Computer Systems Regulated by FDA - What to Know
Overview:The Webinar will focus on the importance of ensuring that the validation of an FDA-regula..
Date : 24th March 2021
Time : This Event is Over and the Recorded Copy is Available
Duration : 1 Hour 46 Mins