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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
Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA in 2025
Overview: The U.S. Food and Drug Administration (FDA) plays a critical role in safeguarding pub..
Date : 27th June 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
Data Integrity and Data Governance for Computer Systems Regulated by FDA in 2025
Overview: As regulatory scrutiny intensifies, data integrity and governance have become corne..
Date : 30th May 2025
Time : This Event is Over and the Recorded Content is Available
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
FDA Regulation of Artificial Intelligence/ Machine Learning Software following the 2025 draft Guidance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
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
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
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-
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
FDA Recent Draft Guidance Related to 21 CFR Part 11, Electronic Records/Signatures for Clinical Investigations
Overview: Companies engaged in human clinical trials must comply with specific regulatory requ..
Date : 01st February 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 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