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2022 ISPE Annual Meeting & Expo

SES113a - ISPE Advancing Pharmaceutical Quality Program: Robust Quality Management Maturity

Oct 31, 2022 3:30pm ‐ Oct 31, 2022 5:00pm


In this interactive presentation, Tami Frederick and Christian Wolbeling will deep-dive into two of the APQ Quality Management Maturity Guides: Cultural Excellence and Process Performance & Product Quality Monitoring System demonstrating how to “assess, aspire, act, and advance” the state of Pharmaceutical Quality within an organization.

Quality Management Maturity is a measure of the advancement of a firms understanding and application of their Pharmaceutical Quality System. In this dynamic session, leaders will learn about the ISPE Advancing Pharmaceutical Quality (APQ) program which is an industry-led approach to advance pharmaceutical quality. Attendees will actively engage in the framework of the APQ QMM program which leads the audience through the “assess, aspire, act and advance” quality maturity based upon international ICH Q10 standards, enhancing the effectiveness of the Pharmaceutical Quality System (PQS).

The ISPE APQ program consists of five Good Practice Guides, one elements of an ICH Q10 Pharmaceutical Quality System, bookended by an optional benchmarking tool developed by University of St. Gallen which was utilized by the US FDA. APQ Guides that have been published and are available to use are: Corrective Action and Preventive Action, Change Management System, and Management Responsibilities and Management Review. The ISPE Process Performance and Product Quality Monitoring System Guide and ISPE Cultural Excellence Guide are to be published in late 2022, completing the full Quality Management Maturity program.


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