Carmen Medina

Carmen Medina uses 35 years of FDA experience to support an array of US and international clients in their preparations for successful FDA pre-approval inspections, QSR, and GCP inspections. She was a former Commissioned Officer in the United States Public Health Service and an FDA Investigator, where she led an international group within Team Biologics and helped usher in the new medical device regulations, QSR. Over the past 30 years, she has been at the forefront of the development, successful approval, and commercialization of hundreds of products, including some of the most important advanced therapeutics and biotech brands. She has conducted over 1200 GCP, GMP and QSR combined inspections resulting in an array of regulatory and criminal actions. Ms.Medina is a graduate of the Columbia University School of Administrative Medicine and School of Public Health, is currently completing her doctoral work at the Pacifica Graduate Institute and is internationally renowned for her work with the biotech, pharmaceutical and medical device industries. She has also published a textbook titled: Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics, Marcel Dekker Publishing.