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KEY GMP REQUIREMENTS OF PHARMACEUTICAL LABORATORIES – UNDERSTANDING THE LATEST FDA & GLOBAL REGULATORY REQUIREMENTS

September 01, 2020 | (10.30AM)
USA (United States of America)
SHARESHARESHARE
The Pharmaceutical laboratories serve one of the most important functions in the manufacturing of drug product. Section I of 21 CFR 211 dictates the requirements for the laboratory controls, and many laboratories consistently received 483’s and Warning Letters indicating that implementation of these requirements is a critical issue with multiple QC laboratories. This session will review the key requirements for a pharmaceutical lab such as analytical validation and verification, GMP requirements for laboratory testing, the stability program. This live trainiing webinar will also introduce the pitfalls of the lab operations and how to establish a workflow to keep the lab in the compliance state.