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Validation of FDA-Regulated Systems with AI, ML & LLMs (ChatGPT)

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

FDA Human Factors Usability Guidance | ISO 62366 & Draft Update Explained

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

FDA Guidance for Use of Social Media by Regulated Industries

FDA Guidance for Use of Social Media by Regulated Industries

Overview: In the early days of social media, regulatory agencies were observers — watching as..

Date : 30th April 2025

Time : This Event is Over and the Recorded Content is Available

Duration : 90 Mins

FDA Regulation of Artificial Intelligence/ Machine Learning Software following the 2025 draft Guidance

FDA Regulation of Artificial Intelligence/ Machine Learning Software following the 2025 draft Guidance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

FDA’s Q-Submission Program for Medical Devices, Software-in-a-Medical Device Products & SaMD with Considerations for Using AI & ChatGPT

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 : 1:00 PM Eastern Time / 10:00 AM Pacific Time

Duration : 90 Mins

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