PDA 530 Quality Risk Management: Risk Control and Risk-Based Decision-Making

Dr. Claycamp is an expert in risk management and decision making who recently retired from the Senior Biomedical Research Service (SBRS) at the FDA. He spent nearly twenty years at the FDA working on human health risk analysis related to both human and food animal drugs. Dr. Claycamp joined FDA-wide groups on the 21st Century GMP Initiatives 2002 and shortly after proposed risk ranking and filtering methods for risk-prioritizing GMP surveillance inspections. In 2007, he joined CDER’s Office of Compliance and subsequently served as Director of the Div. of Compliance Risk Management and Surveillance. Dr. Claycamp worked on a portfolio of risk problems, risk management systems, and decision analysis tools for various levels of drug review and post-marketing risk management. He made frequent research and training presentations at industry and scientific conferences and publishes on these topics; reviews for a variety of risk and regulatory science journals; and leads courses in Risk Analysis and Risk-Informed Decision Making. Dr. Claycamp also served on international working groups who developed “quality risk management” as a systems-based approach integrating quality systems and risk management for drug manufacturing. He was the regulatory lead for the final, internationally-harmonized guideline, ICH Q9: Quality Risk Management. During the recent past, Dr. Claycamp participated in the design and delivery of risk management training for the FDA, PDA, and the PIC/S organization.

Dr. Claycamp’s AB is in Human Biology from Stanford University; MS and PhD degrees are in Radiological Health Engineering from Northwestern University. Prior to joining the FDA, Dr. Claycamp was a Professor at the University of Pittsburgh where he directed graduate training programs in Risk Assessment and Radiation Health while maintaining an active research career including ~80 publications. He previously served on faculties of Radiation Biophysics at the Univ. of Kansas and the Dept. of Radiology at the Univ. of Iowa.