Harold A. Pellerite

Harold A. Pellerite is a Public Health expert based in Washington, District of Columbia. He is also known as Harold "Wally" Pellerite and Wally Pellerite. He has a B.A. Degree in History from Pennsylvania State University in 1970. He was the Assistant to Director of Compliance, FDA for 21 years. He has thirty years experience with the Office of Compliance (OC), Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA). He served as Senior Advisor to the Office of Compliance and Center Directors. He has technical expertise in Corrective and Preventive Action (CAPA), Document Controls, Failure Investigations, Out-of-Specification (OOS) Investigations, Packaging and Labeling, Root Cause Analysis and Clinical expertise in FDA Inspection-483s, Financial Disclosure, Investigator Meeting Planning, Investigator Meeting Presentation, Initiation Visits. He was the former Director, Strategic Compliance at Quintiles Consulti'ng, Rockville, MD. At present he owns a medical devices consultancy services called Pellerite Medical Device Consulting, LLC, where he works with clients in the medical device and biotechnology industries to develop quality assurance and regulatory strategies for compliance with FDA regulations. He is affiliated with Regulatory Affairs Professional Society. He was the recipient of FDA Distinguished Service Award, DHHS Distinguished Service Award, FDA Commendable Service Award, Numerous Outstanding Performance Awards, Medical Device MRA Group Award, DHHS Y2K Certificate of Appreciation, FDA Achievement Award, CDRH Staff College Certificate of Appreciation, Special Recognition Award- Dialyzer Germicide Issue Group, Certificate of Recognition - SMDA 90 and Latex Work Group Award. He is a Peer reviewed compliance expert with emphasis in the areas of Device, Pre-Amendment, and Custom Device determinations having vast knowledge of the statutory and regulatory requirements of the Federal Food, Drug, and Cosmetic Act (the Act).