A Line-Of-Sight Approach To Continued Process Verification Planning

Mike Long, Senior Director of Consulting Services, is a recent contributor to BioProcess Online. Long’s article, “A Line-Of-Sight Approach To Continued Process Verification Planning” addresses the importance of planning for continued process verification (CPV) at the onset of product development. This occurs only when one understands important product and process attributes that must be monitored during the product’s life span.

“Any discussion of CPV planning must begin at Stage 1, process design,” Long commented. “It does not matter if the planning is for a new product, a tech transfer, or a legacy product. The components of Stage 1, and identifying the relative severities of critical quality attributes (CQAs) and important material and process parameters, are critical. Without them, creation and execution of CPV plans is not possible.”

Mike LongMike Long, Ph.D., is a past member of the Parenteral Drug Association’s (PDA’s) Science Advisory Board and co-leader of the PDA’s Quality Risk Management interest group. He is the current lead of the PDA Applied Statistics interest group and co-leader of the PDA’s new CPV task force. Long is a frequent industry speaker/writer who has instructed courses in data analysis at Tufts University’s graduate engineering management program. He taught risk management and quality systems in Regis College’s graduate program in regulatory and clinical research management. Long earned a bachelor’s degree from Worcester Polytechnic Institute, a master’s degree from Tufts University, and a doctorate from Northeastern University.


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