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.
This is my last column in Pharmaceutical Engineering®. It has been my real pleasure and an honor to serve as your International Board Chair. Thank you for your support and I, like you, look forward to another phenomenal year for ISPE in 2024.
Where has 2023 gone? The year is already three-quarters over. The 2023 ISPE Annual Meeting & Expo in Las Vegas, Nevada, is just a few weeks away. And I will be...
It is hard to believe that by the time this column is published, my term as Chair will be half over. We’ve accomplished much, and I’m left wondering, “Where has the year gone?”
2023 continues to move right along—the first quarter is almost over. I remain very optimistic about this year as ISPE International, with support from the International Board, continues to make progress on our 2023 objectives and the 2023—2025 ISPE Strategic Plan.
As we head into 2023, it is hard to believe that it has been four years since the COVID-19 pandemic started to impact our lives and transition us to a new normal. It is also amazing how much technology and innovation continued to advance in those four years to allow our industry to develop new vaccines and innovative products to meet the world’s challenges.