An assessment can identify the critical systems and the gaps in compliance based on intended use, says Siegfried Schmitt, vice president technical, Parexel. Q. We recently performed a detailed ...

Regulation and the pharmaceutical sector are intrinsically linked. Indeed, it’s no exaggeration to state that the global pharmaceutical sector is one of the most heavily regulated industries in the ...

Computer System Validation is a regulatory requirement under ICH GCP and 21 CFR Part 11 but it also makes good business sense to ensure that computerized systems will perform consistently as expected.

Dublin, April 20, 2023 (GLOBE NEWSWIRE) -- The "Computer System Validation ( CSV) 3 Day Virtual Seminar" training has been added to ResearchAndMarkets.com's offering. This course is designed to ...

Dublin, March 10, 2025 (GLOBE NEWSWIRE) -- The "FDA Trends for Computer System Validation (CSV) Compliance and Enforcement" training has been added to ResearchAndMarkets.com's offering. Upon ...

The purpose of this course is to provide candidates with some practical tools for validation - including qualification, process validation and analytical method validation. Validation is a regulatory ...

In this webinar, you’ll learn about the importance of computer system validation (CSV), how frequently it should be performed, and the benefits it can have to help meet FDA regulations and quality ...