LTJG Seneca D. Toms is a U.S. Public Health Service Commissioned Officer serving as Drug National Expert with the FDA’s Officer of Regulatory Affairs. He is responsible for providing technical advice and assistance within FDA headquarters, to field offices, other federal agencies, state, local, foreign regulatory agencies, and the regulated industry on issues related to pharmaceutical drugs. Toms has experience conducting complex finished drug, biotechnology, and active pharmaceutical ingredient inspections both domestically and internationally. He serves as an instructor at national trainings for FDA investigators, analysts, and state officials on the topics of data integrity, computerized systems, sterile drug manufacturing, and conducting inspections. He has also served as an instructor of biotechnology and cGMP in academia.
Toms received undergraduate degrees from North Carolina State University, a Master of Science in Biotechnology from Johns Hopkins University, and a Master of Science in Environmental Health and a Graduate Certificate in Public Health from East Carolina University. He is an FDA Certified Drug Investigator, and Regulatory Affairs Certified (RAC).