Laura Fontan is a Senior Consumer Safety Officer (CSO) at the Center for Biologics Evaluation and Research (CBER), Division of Manufacturing Quality (DMPQ) at FDA. As a CSO, Laura evaluates facility design, operation, manufacturing, validation, testing procedures and compliance with Good Manufacturing Practices (GMPs) for Biologics License Applications (BLA) and supplements for biological product applications. Laura is also a lead inspector for pre-licensing and pre-approval inspections for BLAs and supplements. As a lead inspector, she assesses the facility’s manufacturing practice and conformance to applicable FDA regulations (e.g., Current Good Manufacturing Practice For Finished Pharmaceuticals - 21 CFR 211 and 21 CFR 600) and standards. Most recently, Laura was a reviewer in the team effort for vaccine authorization and approval as part of the Operation Warp Speed Federal COVID19 Response. Prior to joining CBER in 2018, Laura was a CSO in the Center for Drugs Evaluation and Research (CDER), in the Office of Pharmaceutical Quality. Laura has received multiple awards during her time at FDA, including the CBER Outstanding Service Award in 2022.
Before joining FDA, Laura worked for over 25 years in the biopharmaceutical and pharmaceutical industry in various roles in manufacturing, validation, process improvement, quality assurance and as a consultant. During this time, she co-authored PDA Technical Report No. 39 Cold Chain Guidance for Medicinal Products: Maintaining the Quality of Temperature Sensitive Medicinal Products through the Transportation Environment, 2005. She also presented at the PDA annual meeting, Atlanta, GA November 2005. She has been involved in multiple manufacturing facility startups and validation of facilities for sterile liquid and lyophilized drug products, including new facilities at Human Genome Sciences (MD) and Genentech Inc. (CA). Laura holds a bachelor’s degree in molecular biology from the University of California, Santa Cruz, and an MBA from University of Phoenix.