Monica Caphart is a Consumer Safety Officer in the Case Management and Guidance Branch Division of Manufacturing and Product Quality, Office of Compliance, Center for Drug Evaluation and Research, FDA. She joined the FDA as a pharmaceutical chemist in the New York Regional Laboratory, later becoming a scientific coordinator in the FDA’s Division of Field Science, Office of Regulatory Affairs. She joined CDER’s Office of Compliance in 1993. Her responsibilities at CDER include reviewing proposed regulatory actions for conclusiveness and acceptability of evidence, nature and extent of deviations from cGMPs and appropriate regulatory action strategy, and advising field investigators and industry on Center policies regarding laboratory cGMP issues. Prior to joining the FDA, she worked as a Research Assistant in the Division of Thrombosis Research at the Mt. Sinai Medical Center in New York and as Quality Control Chemist in industry. Caphart holds a BS degree in Chemistry and an MS degree in Pharmacology.