Monica Caphart, MS, M.P.H. FDA

Monica Caphart is the Leveraging and Collaboration Program Manager in ORA's Division of Human Resource Development (DHRD). Her +26 year FDA career spans service in ORA and CDER. She began as an analyst in the Northeast Regional Laboratory, moved to ORA's Division of Field Science as a Scientific Coordinator, then to CDER's Office of Compliance where she served as a Senior Compliance Officer. Monica later returned to ORA where her staff included the ORA National and Program Expert Investigators for Medical Products and Tobacco; before assuming her current position in DHRD. In 1997 she was selected as the CDER, Office of Compliance technical/regulatory specialist on pharmaceutical laboratory CGMPs. In 2000 Monica was awarded a Mansfield Fellowship (a program whose focus is to enhance US/Japan government relations) which enabled her to study Japanese for a year, followed by a year working at Japan's Ministry of Health, Labor and Welfare, where she learned about Japanese GMPs. She also able completed an internship at a Japanese Pharmaceutical Company during her fellowship year in Japan. In 2008, Monica was seconded to the European Medicines Agency as a Visiting Expert. She holds a bachelor's degree in Chemistry and master's degrees in Pharmacology and Public Health. Monica is a member of FDA's foreign inspection cadre and is a training resource for FDA.