Kris Evans is currently the executive director of Quality Sciences at Amgen, Inc. In 2007, Mr. Evans retired from the US Food and Drug Administration after serving for twenty years as a Field Investigator and later in CDER’s Office of Compliance on the Guidance and Policy Team. While at FDA he conducted biopharmaceutical inspections worldwide, specializing in sterile manufacturing operations. He was also responsible for drafting GMP policy and guidance documents, primarily on aseptic processing, sterilization and process validation. He is very active in the Parenteral Drug Association (PDA) as a member of the Science Advisory Board and several task forces responsible for technical reports in the sterilization and aseptic processing arenas. Mr. Evans received a degree in Biomedical Engineering from Duke University in 1987.