FDA/CDER/OPQ/OPF/DIA/BI
Quality Assessement Lead
Dr. Ruth Moore serves as a Quality Assessment Lead at FDA in the Division of Inspectional Assessment (DIA), Office of Process and Facilities (OPF). She conducts reviews of the facilities and manufacturing controls, and performs PAI inspections to assess the manufacturing capabilities of firms listed in NDA, BLA and ANDA marketing applications. Prior to joining FDA she worked in industry for sixteen years in various technical and managerial positions in Pharmaceutical Analytical Development and Quality Control. She obtained her Ph.D. in Chemistry from the University of Waterloo, Ontario, Canada, and conducted post-doctoral studies at Indiana University, Bloomington, and at Stanford University California.