Michael L. Rutherford

Retired, Computer Systems Quality & Data Integrity

Michael Rutherford is a retired pharmaceutical industry quality professional with almost 36 years of experience. In November 2023, he retired from Syneos Health as Executive Director, Quality Assurance, Computer Systems Quality and Data Integrity where he was responsible globally for computer systems quality and data integrity. He previously retired from Eli Lilly and Company in 2017 where he held numerous technical, administrative, and operational leadership roles within the Laboratory, Quality, and Medicines Development Unit. 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 has been involved with ISPE and GAMP® since 2003. He currently serves as Immediate Past Chair on the ISPE International Board Executive Committee and Board of Directors after serving as Board Chairman in 2022-2023. He also served as a Board member for the ISPE Foundation. He is a member and Past Chair of the GAMP CoP Global Steering Committee, a Past Chair of the GAMP Americas Steering Committee, a sponsor of numerous GAMP Special Interest Groups (SIGs), including those on Data Integrity and the Cloud, and a contributing author to numerous GAMP Guides and Good Practice Guides. He has organized and chaired numerous ISPE and GAMP related conferences and was the 2019 ISPE Annual Meeting Chair. Mike received the 2014 ISPE Max Seales Yonker Member of the Year Award and the 2016 ISPE Joseph X. Phillips Professional Achievement Award. Mike has a BS degree in Chemistry from Delaware Valley University, and an MS degree in Analytical Chemistry from the University of Kentucky.

Features

Why ISPE GAMP® Supports the FDA CDRH: Case for Quality Program

1 November 2019

The US FDA Center for Devices and Radiological Health (CDRH) Case for Quality program promotes a risk-based, product quality–focused, and patient-centric approach to computerized systems. This approach encourages critical thinking based on product and process knowledge and quality risk management over prescriptive documentation-driven approaches.