Peter D. Smith Smith GMP Consulting

Peter Smith formed his own company following retirement from PAREXEL Consulting in April 2018 where he worked for 23+ years in various positions. His last position was Vice President, Technical where he worked with clients in the pharmaceutical and biologics industry worldwide, which continues with his current company. Mr. Smith joined PAREXEL (then KMI) in 1994 following a 22-year FDA career. At the FDA, he worked in the field and at headquarters as an Investigator, specializing in pharmaceutical GMP/GCP and medical device inspections. His last position at FDA was Associate Director, International and Technical Operations Branch, Division of Field Investigations. In this capacity, he managed the FDA’s Foreign Inspection Program. During his FDA career, he conducted inspections of pharmaceutical plants in the U.S., Europe, Asia, South America and Australia. Mr. Smith has primary expertise in GMPs for sterile and non-sterile drug dosage forms, active pharmaceutical ingredients, management of inspections, including Pre-approval and foreign inspections, GMP quality systems and FDA regulatory issues. He has experience in antibiotics, radiopharmaceuticals, non-clinical (GLP) laboratory studies, and GCP compliance. He works with biologics and pharmaceutical client companies to achieve site facility compliance, implement GMP/Quality System corrective action plans, prepare clients for successful regulatory inspection outcomes, due diligence audits, and conducts GMP audits and assessments. He is a highly experienced public speaker and trainer in GMP and FDA inspection readiness topics. Mr. Smith holds a BS in Biology from Roger Williams University, Bristol, Rhode Island. He is a member of PDA, ISPE and RAPS, and is an Associate Adjunct Professor at the University of Rhode Island, College of Pharmacy, providing lectures to pharmacy students.