Nicole Trudel FDA

Nicole Trudel has 15 years of experience at CBER's Division of Manufacturing and Product Quality in the Office of Compliance and Biologics Quality.  Her experience includes a wide range of CMC and facility reviews and inspections for bacterial and viral vaccines, recombinant products, in vitro diagnostic test kits, plasma fractionated products, allergenic extracts, cord blood, cell and gene therapies, devices, and combination products.  Nicole provides advice and guidance to sponsors during industry meetings on complex issues associated with manufacturing facilities and equipment, manufacturing processes, technological changes, and quality systems to ensure CGMP compliance. Nicole also has experience reviewing PMA, 510(k), and NDA submissions.  She supports internal and external training and establishment of internal policy and procedures within her various areas of technical expertise and participates in numerous policy groups addressing CGMP, harmonization, and review and inspection related issues.  Her areas of expertise include CGMP and CMC as applied to facilities, equipment, manufacturing, human drugs, medical devices, biologics, and combination products.  In addition to her service with the FDA, Nicole has nine years of industry and civil service experience in biological and chemical defense systems.  She holds a B.S. degree in Mechanical Engineering.