LCDR Tara Gooen is a compliance officer in the Division of Manufacturing & Product Quality in CDER. She has been with FDA for 7 years. She began her servicer with FDA at the New Jersey District Office as an investigator and performed primarily drug manufacturing inspections, both domestic and international. In 2007, she transferred to her current position as a compliance officer on the Guidance and Policy Development Team. LCDR Gooen is involved with the development and modernization of CGMP guidance and policy for the pre-approval inspection and post-approval inspection programs, as well as reviewing regulatory cases in the area of drug CGMPs. She continues to be a lead investigator for drug manufacturing CGMP pre-approval and surveillance inspections. Prior to joining FDA, she worked in pilot- and small-scale CHO cell culture and purification. She is an officer in the United States Public Health Service. LCDR Gooen received her B.S. in chemical engineering from Cornell University and her Masters of Biomedical Science from the University of Medicine and Dentistry of New Jersey.