Kurtis Epp has over thirteen years of experience in the biopharmaceutical industry. He has held development and manufacturing positions at G.D. Searle, Pharmacia, and Pfizer and has been in manufacturing management with BioTechLogic since 2004. His experience includes API manufacturing, technology relocation, production scale-up, process risk assessment, process characterization, Design of Experiment, process validation, Continued Process Verification, and product supply chain management at internal and third-party manufacturing sites both domestically and internationally. He has been a member of the Parenteral Drug Association since 2009 and he is currently part of the PDA’s task force for Process Validation and Verification. His has recently given presentations at IVT’s Validation Week in both the US and Europe as well as at the 2011 PDA Annual Meeting Post-Conference Workshop on the FDA’s Process Validation guidance document.