Develop a Process Validation Roadmap


Develop a Process Validation Roadmap:
Case Studies Show How
to Satisfy FDA’s Scrutiny

Your office, May 28, 2014


Meet your instructor

Rich Yeaton, validation manager for Mangan Biopharm, has more than twenty years of 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. There, he developed and improved new process equipment and was told to validate what he had designed. He moved on to help start Phoenix Imperative, an engineering and validation consulting company serving the biopharmaceutical industry. A key achievement with Phoenix was leading validation teams at two MedImmune cell culture facilities to assist MedImmune to obtain its first two commercial licenses. He has since worked with small start-up companies and larger operating companies such as Merck, Genzyme, Wyeth and Lonza. He has in-depth experience with facility shutdowns and start-ups. Rich recently helped Avecia Biologics, a microbial fermentation contract manufacturer, to successfully prepare for its first preapproval inspection held in January 2009. He is a member of the ASME, the ISPE and the PDA and has degrees in electrical engineering and mechanical engineering from Lehigh University.