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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
Best Practices in Preparation for an FDA Computer System Audit in 2025
Overview: In 2025, the FDA's expectations for validated computer systems have never been high..
Date : 31st July 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 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
Sampling Plans for Verification and Validation, Production Process Validation and Production Control
Overview: When design flaws go unnoticed until late in production—or when a batch fails inspe..
Date : 23rd May 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
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
Project Management for CSV in FDA-Regulated Environments (CSA, GAMP®5 2nd Ed.) — with a Brief AI/ChatGPT Overview for PM Support
Overview: Computer System Validation (CSV) has underpinned FDA compliance in regulated industr..
Date : 30th October 2025
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 Mins