(FALL 2009)

A required course in the Certificate Program in Medical Product Development.
Learn about the essential elements of Quality System Regulations (QSR's) and Good Manufacturing Practices (GMP's), how there is a commonality between them, and how to develop a global approach to Quality Systems in order to satisfy international requirements of ISO 9001:2000 and ISO 13485:2003. A detailed analysis of these systems and practical 'how to' recommendations and approaches are presented, with particular emphasis on the United States Food and Drug Administration (FDA) QSR's and GMP's. See enrollment confirmation for login information.

Albert Rego, Ph.D., M.B.A., is a scientific consultant to the regulated industries, with over 20 years of experience in the pharmaceutical and medical device industries. His areas of specialization are in the national and international regulatory aspects of the scientific testing requirements for chemical, biological and sterilization technologies. Rego's experience is focused on performing, directing, designing, and evaluating clinical and non-clinical studies for pharmaceuticals and medical devices. Selective expertise includes chemical stability testing, medical device evaluations, statistical design and interpretation, regulatory submissions, chemical hygiene plans, analytical chemistry methodologies, and sterilization validation.