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2021 ISPE Annual Meeting & Expo

Concurrent Session: Advancing Pharmaceutical Quality - Quality Management Maturity

Nov 2, 2021 10:30am ‐ Nov 2, 2021 12:00pm


Concurrent Session: Advancing Pharmaceutical Quality - Quality Management Maturity|This session focuses on Advancing Pharmaceutical Quality (APQ) and specifically the APQ Quality Maturity Framework that has been developed by ISPE over the past 3 years evolving from ISPE’s research in response to FDA Quality Metrics draft guidance and ISPE’s Cultural Excellence report.  This industry-for-industry quality maturity framework provides an Assess, Aspire, Act and Advance model for quality management maturity.  In this session, industry experts will provide the APQ Quality Management Maturity Framework and will provide their learnings from the Quality Metrics Feedback Program.  FDA will present its journey toward assessing quality management maturity as well as their learnings from the FDA Quality Metrics Feedback Program.  Further, FDA will provide an update on the Quality Management Maturity Pilot.


  • Tami J. Frederick, Senior Director, Corporate Quality Systems & Cultural Excellence, Perrigo

Session Leader(s):


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