In the global market for medical products, country and regional laws and regulations are in a constant state of revision. Requirements become more stringent as governments work to protect the public health of their citizens, improve healthcare, and in some cases protect their local industries against foreign competition. As medical technologies become more complex, how does an organization develop and revise the quality system to meet these dynamic and constant revisions without re-creating multiple quality system processes? How does an organization maintain an efficient and effective quality system? This discussion will provide some practical answers to these questions. 
Tom Hutchinson is the Vice President of Regulatory Affairs at Davol Inc., a subsidiary of CR Bard. Previously, he was responsible for both Quality Assurance and Clinical Affairs. Prior to working at Davol, he held positions in the pharmaceutical industry - Senior Director, Global Manufacturing Compliance and Director, Devices at Pfizer Inc.; Director, Global Compliance Management at Pharmacia Corp. His initial work in the life sciences industry was as Director, Quality Management and Regulatory Affairs at the Medical Products division of Becton Dickinson and Co. Before entering the life sciences industry, he had a number of manufacturing and corporate quality assignments at Polaroid, Chomerics Inc., and Avery-Dennison. Tom has over 30 years of quality system experience. He holds an MS in Quality Management, a BS in Microbiology/Molecular Biology, has numerous ASQ credentials (Senior Member, QMOE, CQA, CBA), is a certified Six Sigma Black Belt, and participates actively in numerous professional organizations (RAPS, PDA, ISPE, CPC).