Kip Priesmeyer has been working as an independent consultant (Kip Priesmeyer & Associates, LLC) since October 2009. Prior to this, he was an FDA Investigator for 34 years (1972-2006), and was a member of Team Biologics the last 9 years of his career. While with FDA, Kip was recognized for his expertise in conducting regulatory inspections of biopharmaceutical manufacturers that produce biotech therapeutics, human vaccines, plasma derivatives, as well as related sterile dosage forms. While with the Agency, Kip was a Level II Certified Drug Auditor and was the FDA lead for ISPE’s Biopharmaceutical Facilities Baseline Guide. After retiring from FDA, Kip joined Novartis Vaccines & Diagnostics, Inc., in July 2006, and served as a subject matter expert providing technical support for the preparation for new product launches requiring BLA and supplemental approvals, consulted on new construction projects, and prepared production sites for Pre-Approval, as well as comprehensive Team Biologics inspections. Kip retired from Novartis in 2009 to launch an independent consulting company. He holds memberships in ISPE as well as PDA and is a graduate of Washington University in St. Louis, MO.