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Best Practices in Preparation for an FDA Computer System Audit in 2025

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

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

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

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

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

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