John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and has managed Analytical Research, Quality Control, and Quality Assurance functions for major pharmaceutical firms. Since 1994 Dr. Lanese has been an independent consultant. He has consulted with small and large medical device and pharmaceutical companies, including companies under FDA Consent Decree, API and excipient manufacturers, electronic firms and other manufacturing organizations. Dr. Lanese lectures throughout the world and presents webinars on a variety of topics related to Quality Systems, GMPs, APIs, laboratory operations, calibration, change control, deviations and product reviews for clients and seminar, webinar and conference providers. In 2007, Jerry received the Kenneth Chapman Industry Recognition Award for his contributions to the Pharmaceutical industry. Jerry is a member of the Editorial Board of the Journal of GXP Compliance and he is the co-author of a continuing series of articles in the Journal of GXP Compliance, “GXP Talk”.