(FALL 2009)

A required course in the Certificate Program in Medical Product Development.
From concept through development to approval, the Medical Product Life Cycle integrates design, development, validation, and commercialization. Further your understanding of the phases, requirements, and deliverables of the Product Life Cycle in order to manage projects and multifunctional teams. Topics covered include Design Control, FDA guidances, corporate procedures, start-up company experiences, marketing tools, concept generation, intellectual property, risk management, statistics, regulatory strategy, and time to market. Guest experts and real world examples augment the learning experience.

Jack C. Dhuwalia, M.S.ChE., M.B.A., is president of JD Consulting. He has over 28 years of broad experience in medical product development, quality systems, project management, operations, materials application, and process engineering. Dhuwalia is an active senior member of industry organizations. He is a certified Six Sigma Black Belt, Toastmaster DTM, presents programs in ISO 13485:2003, supplier quality, design controls, root cause analysis, failure analysis, CAPA, materials controls, risk management, and lean manufacturing.