Peter D Smith
Parexel International, USA
Biography
Peter D Smith joined PAREXEL (then KMI) in 1994 following a 22-year FDA career and works with clients in the pharmaceutical and biologics industry worldwide. At the FDA, he was an Investigator, specializing in pharmaceutical GMP/GCP and medical device inspections, later serving in FDA Headquarters where he managed the FDA’s Foreign Drug Inspection Program. He has primary expertise in GMP for Active Pharmaceutical Ingredients, sterile and non-sterile dosage forms, management of Pre-Approval Inspections, GMP/Quality Systems and FDA regulatory issues. He holds a BS in Biology from Roger Williams University in Rhode Island. He is a Member of ISPE and PDA, and an Associate Adjunct Professor at the University of Rhode Island, College of Pharmacy.
Abstract
Abstract : The Importance of Proper Change Management
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