Michael Rutherford

  PhotoMichael Rutherford has a BS degree in Chemistry from Delaware Valley University, Doylestown, PA, and an MS degree in Analytical Chemistry from the University of Kentucky, Lexington, KY. Over the last 28 years at Eli Lilly and Company, Mike has held numerous technical and administrative roles within the Quality organization, including the Quality Control Laboratories, Corporate Quality Assurance, and the Global Quality Labs. He has utilized his broad technical expertise to support and influence a variety of global projects and compliance initiatives. Mike is recognized as a global technical expert in ER/ES, data integrity, computer systems validation and quality, as well as laboratory automation and laboratory informatics. Mike served as the Global Quality System Manager for Computer Systems, responsible for assuring that regulatory and internal quality standards were defined, communicated, and appropriately implemented worldwide for GxP computer systems. In the Global Quality Labs, Mike was responsible for providing lifecycle management and system ownership for global laboratory informatics solutions. For the last 5 years, Mike has served as Consultant – Business Systems Support - Laboratory and Quality Systems, responsible for the technical, administrative, and operational leadership for multiple laboratory and quality related computerized systems, as well as information protection projects across the Lilly Medicines Development Unit. Mike has been involved with ISPE and GAMP leadership since 2003 and currently serves as the Chair of the GAMP COP Global Steering Committee, the past Chair of the GAMP Americas COP Steering Committee, as well as the sponsor of numerous GAMP Special Interest Groups (SIG’s), including those on Data Integrity and the Cloud. He has organized and chaired numerous ISPE and GAMP related conferences worldwide and currently serves as the 2016 ISPE Annual Meeting Education Program Chair. He is also coordinating an ISPE global effort on Data Integrity. Mike was the recipient of the 2014 ISPE Max Seales Yonker Member of the Year Award.