023 - A Broadway Performance Analogy for API Process Validations with Jim Mencel

Feb 26, 2021 · 43m 53s
023 - A Broadway Performance Analogy for API Process Validations with Jim Mencel
Description

Jim Mencel is Senior Drug Substance Consultant at Design Space InPharmatics. With an extensive background in CMC management, Jim has a wealth of knowledge on the topic of process validation....

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Jim Mencel is Senior Drug Substance Consultant at Design Space InPharmatics. With an extensive background in CMC management, Jim has a wealth of knowledge on the topic of process validation. Process validation is an integrated and mandatory process in the pharmaceutical industry to ensure all processes are in compliance with regulatory standards. In this episode, Jim provides his thoughts on the significance and science of process validation in the pharmaceutical industry as it pertains to drug substances. He discusses the evolution of batch documentation, expounds on PAR and CPP and stresses the importance of communication.
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Author Tom Zeeb
Organization Tom Zeeb
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