Mr. Scott Hamm is a Principal Consultant for Commissioning Agents, Inc. and has over 28 years of engineering and management experience in a regulatory environment. He has a strong C&Q background and experience developing quality system documentation and processes (e.g., standards, policies, procedures) for pharmaceutical and medical device manufacturers. Mr. Hamm was instrumental in developing the corporate C&Q program for Eli Lilly during his 12 years of employment and managed their corporate engineering group responsible for providing C&Q and M&R support to all global manufacturing sites. He has led many training sessions within corporations and at industry conferences on various compliance topics (e.g., user requirements, design qualification, risk-based C&Q, GDPs, etc.). In addition, he has over 10 years of project management experience and has managed multi-million-dollar capital projects, the most recent being an $80MM project to convert an existing facility to a parenteral commercialization launch facility. Mr. Hamm has served as a member of the ISPE Steering Committee for the Commissioning and Qualification Community of Practice. He has a B.S. in Electrical Engineering from Purdue University.