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FDA Regulation of Artificial Intelligence/ Machine Learning Software following the 2025 draft Guidance

FDA Regulation of Artificial Intelligence/ Machine Learning Software following the 2025 draft Guidance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

US FDA Requirements for Medical Products Labeling / UDI

US FDA Requirements for Medical Products Labeling / UDI

Overview: The world of medical product labeling in the United States is governed by a complex ..

Date : 10th February 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 2024

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

Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA in 2024

Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA in 2024

Overview: The U.S. Food and Drug Administration (FDA) plays a critical role in safeguarding p..

Date : 30th August 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-

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

Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity

Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity

Overview:The use of Excel in FDA-regulated environments extends beyond basic data organization and..

Date : 29th January 2024

Time : This Event is Over

Duration : 90 Mins

Risk Based Design Control Requirements and Industry Best Practices for Medical Devices

Risk Based Design Control Requirements and Industry Best Practices for Medical Devices

Overview: Design flaws — not manufacturing errors — continue to be the leading cause of medica..

Date : April 29, 2025

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

Duration : 60 Mins

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