Speakers

CAPT Tara Gooen Bizjak is the Director of the Manufacturing Quality Guidance and Policy Staff in CDER, Office of Compliance, Office of Manufacturing Quality and is an engineering officer in the United States Public Health Service. Tara has been with the FDA for 21 years and has focused in the area of drug manufacturing, current good manufacturing practice (CGMP) inspections, and related policy. She started as a field investigator in the New Jersey District, and has also served as a senior science policy advisory in the Office of Pharmaceutical Quality in the area of quality metrics and emerging technology, branch chief in the area of drug manufacturing pre-approval inspections, and a senior advisor in the Office of Regulatory Affair. CAPT Bizjak is an ASQ (American Society for Quality) Certified Quality Engineer and Quality Improvement Associate. She received a B.S. in Chemical Engineering from Cornell University and a Masters in Biomedical Science from Rutgers University.