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

CDR Donald Ertel MS, MT (ASCP)

CDR Donald Ertel MS, MT (ASCP) U.S. FDA Branch Chief / Program Manager, OCBQ, CBER

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 Branch Chief for DMPQ's Manufcaturing Review Branch 3. For over 13 years, CDR Ertel’s primary duty has been scientific review, and supervisory oversight of reviews, of (CMC) of BLAs and PMAs. As a CBER lead inspector, he performed, 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.