CDR Donald B. Ertel, MS, MT(ASCP) U.S. FDA

Commander Donald Ertel received his BS Degree in Medical Technology from the University of Maryland and a master’s degree in Regulatory Affairs / Quality Assurance from Temple University School of Pharmacy. CDR Ertel currently serves in the role of Team Lead for DMPQ. For over 12 years, CDR Ertel’s primary duty has been scientific review (CMC) of BLAs and PMAs. As a CBER lead inspector, he performs, and trains new inspectors in, pre-license/approval inspections for BLAs and supplements; and has performed numerous facility inspections, domestically and internationally. CDR Ertel has over 30 years of experience working in quality assurance and compliance in and with regulated industries of blood banking & cell therapy (prior employment at Johns Hopkins Hospital), biotechnology, and pharmaceuticals (prior employment at Shire Pharmaceuticals). As an USPHS officer, CDR Ertel has participated in multiple deployments in support national crisis including twice to the COVID-19 global response.