Mark is a Technical Lead and Production start-up manager responsible for the start-up of a new primary packing facility in AstraZeneca in the UK. He leads multi-disciplinary team responsible for the validation and associated Operations start up activities for a state-of-the-art aseptic syringe assembly line through to stable commercial supply. Previously, Mark was the global lead for Continued Process Verification (CPV) and the lead author for the cross-functional quality standards in AZ. He managed the process maturity, led the associated data strategy and chaired the global network from AZ’s production facilities. Mark has an MSc. in Analytical Chemistry and held various development and manufacturing roles in AZ. A Six Sigma certified Black Belt he has a passion for coaching and process robustness. As an active member of ISPE; he has delivered podium presentations at ISPE conferences, co-chairs the PAT & Lifecycle control strategy CoP and is member process validation team.
Emerging Leaders (EL) within the pharmaceutical industry have been invited from around the world to participate in the 2022 ISPE Annual Meeting & Expo Program Committee. This unique opportunity allows...
The life cycle approach to process validation stresses the need for continued monitoring of process performance to ensure that the manufacturing process remains stable and predictable, i.e., in a state of control. This life cycle stage is known as continued process verification (CPV) or ongoing process verification (OPV).1
1US Food and Drug Administration Center for Drug Evaluation...