Kurtis A. Epp, Director, CMC Lead, CSL Behring, Global R&D has seventeen years of experience in the biopharmaceutical manufacturing industry. He has held development and manufacturing positions at G.D. Searle, Pharmacia, and Pfizer and was a senior consultant with BioTechLogic for ten years prior to joining CSL Behring in 2013. His experience includes API manufacturing, technology relocation, production scale-up, process risk assessment, process characterization, Design of Experiment, process validation, risk assessment, Quality by Design, Continued Process Verification, and product supply chain management at internal and third-party manufacturing sites both domestically and internationally. He has been an active member of ISPE since 2011 and part of their Product Quality Lifecycle Implementation working group, responsible for authoring industry discussion papers on various aspects of implementation of lifecycle process validation concepts. He has recently given presentations at IVT’s Validation Week in both the US and Europe as well as at the PDA Annual Meeting Post-Conference Workshop on the FDA’s Process Validation guidance document and at ISPE’s conference on Continued Process Verification. He is currently serving as co-leader of a global QbD team at CSL Behring, responsible for writing and implementing global policies for QbD implementation across multiple global R&D and manufacturing sites.