Michele Forster PhD U.S. FDA

Michele Forster, PhD, currently holds the position of Associate Director for Manufacturing Quality in CBER’s Office of Compliance and Biologics Quality (OCBQ). In this role, she provides advice on compliance with Current Good Manufacturing Practice (CGMP) requirements for CBER-regulated products. Prior to this, she worked as Consumer Safety Officer in the Biological Drug and Device Compliance Branch (BDDCB) in the Division of Case Management (DCM) in CBER/OCBQ and in the Office of Regulatory Affairs (ORA) where she reviewed compliance cases and drafted compliance documents. She started her career with the FDA as an investigator, first in the Detroit District Office—performing inspections of drug product manufacturers—followed by three years on Team Biologics—performing inspections of products licensed by CBER.