Continued Process Verification: Achieving Compliance and a Competitive Advantage

Continued Process Verification (CPV) is a compliance requirement of all drug manufacturers. It presents formidable challenges unlike any other regulation. However, it also presents an opportunity to not only deliver compliance, but also improves your organizational efficiency and strengthens your competitive advantage. A key aspect of Continued Process Verification that makes it a challenge to implement is its scope. Not only does it require data evaluation from the start to the end of the production process, but it also requires a multidisciplinary team to implement. This broad scope in terms of ‘processes covered’ and ‘disciplines needed’ means that CPV is not simply a departmental initiative, but an enterprise initiative.

This webinar is given from the perspective of a recognized consulting organization with experience assuring quality and compliance efficiently at seven of the top 10 life science companies, as well as the leading GxP Data Aggregation and Analytics system provider.

This presentation will include:

• What is Continued Process Verification
• Common Continued Process Verification pitfalls and how to avoid them
• Proven Continued Process Verification strategies
• How to leverage Continued Process Verification for greater operational efficiency

Common pitfalls to be discussed include companies deploying CPV at a department level only. Manufacturing departments responsible for a single process step may generate run charts of their critical quality attributes (CQAs) as common for CPV, but this information will fail to identify intradepartmental factors that impact the process. Challenges related to intradepartmental process analysis can then be compounded by lacking the disciplines needed for CPV. Pressures to run a lean manufacturing department commonly result in employees being focused in the manufacturing discipline specific to their area and not the disciplines needed for CPV. This typically results in a team with insufficient statistics and cross-department expertise to adequately control the process. This is also why CPV must be supported by a multidisciplinary team with knowledge that spans all manufacturing process departments.

Speakers

Matt Brawner, Director, Sales Execution, Sequence

Mr. Matt Brawner has over 18 years of experience working with drug and medical device companies within the biopharmaceutical Industry. As a Lean/6 Sigma Black Belt with experience holding various roles within quality, engineering, automation, information & technology, automation, manufacturing and organizational excellence, Matt strives to deliver innovative and high-value quality solutions. Matt was most recently recognized for his leadership in a successful regulatory action remediation, as well as consolidating quality management systems (QMS) following a merger between two global companies. Matt holds a Master’s Degree in Manufacturing Technologies from East Carolina University and an MBA from Kenan-Flagler Business School (UNC). He also holds patents spanning the pharmaceutical, fitness and water conservation industries. He is currently a director with Sequence Inc. based out of Morrisville (Research Triangle Park), North Carolina.

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Aaron Spence, Business Analyst, Biovia

Aaron Spence has worked in the life science manufacturing industry for seven years and has graduate degrees in clinical health psychology and applied statistics. He has developed CPV guidelines, implemented CPV technology solutions and provided statistical consulting for various major pharmaceutical and biotech companies. Currently, Aaron is working for Dassault Systemes BIOVIA to enable partners and customers in the adoption and value-realization of life science software solutions.

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