Mr. Patten has over 30 years of experience CMC regulatory he has recently retired from the FDA after 13 years, where he was the Associate Director of Manufacturing. In his role at the FDA he has reviewed numerous CMC regulatory applications. He was an integral part of the Office of Manufacturing Quality. At the FDA, the Office of Manufacturing Quality, he evaluated compliance with manufacturing requirements for drugs based on inspection reports and evidence gathered by FDA investigators. Office of Manufacturing Quality develops and implements compliance policy and takes risk-based actions to protect the public from adulterated drugs in the U.S. market.
Copyright © 2021 PharmaPro Consulting Inc. - All Rights Reserved.