Rich Yeaton has over twenty five years’ experience working in FDA regulated industries. He was initially introduced to GMP operations on the Devices side as a Development Engineer in DuPont’s Medical Products division, where he developed and improved new process equipment, and then was told to validate what he had designed. He moved on to help start Phoenix Imperative, an Engineering and Validation consulting company serving the BioPharm industry. A key achievement with Phoenix was leading validation teams at two MedImmune cell culture facilities to assist them to obtain their first two commercial licenses. He has since worked with small startup companies and larger operating companies such as Merck, Genzyme, Wyeth and Lonza. He has in-depth experience with facility shutdowns and startups. He recently assisted Avecia Biologics, a microbial fermentation Contract Manufacturer, to successfully prepare for their first Pre Approval Inspection. He is currently working with a GMP Operating company to manage Process, Cleaning and Equipment validation efforts for a new combination product under development. He is a member of ISPE, PDA and AAMI and has degrees in Electrical Engineering and Mechanical Engineering from Lehigh University.