Drawing from a 30+-year career in quality and leadership roles across global companies in the pharmaceutical industry, Mike Porter has extensive GxP knowledge in the areas of medical devices, manufacturing, laboratory, and clinical trials. He has honed a collaborative approach to implement efficient, effective, and sustainable quality management system solutions that are compliant with global regulatory requirements and industry best practices— appropriate whether targeting commercial, start-up, or clinical operations. Porter has held leadership positions at Eli Lilly & Company, Myriad Genetics, and PPD (Pharmaceutical Product Development) in addition to his consulting experience.  He is actively involved in ISPE through co-teaching ISPE’s “Applying Quality Risk Management” course and is a member of ASQ. He holds a M.Sc. biomedical engineering from Clemson University, and a B.Sc. engineering science and mechanics from Virginia Tech.