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2020 ISPE Annual Meeting & Expo


NA20CENOV1/SES205 - The Importance of Quality Management Maturity


Nov 2, 2020 1:00pm ‐ Nov 2, 2020 2:30pm

Description

The Importance of Quality Management Maturity | FDA introduced interest in quality management system maturity and a rating system of maturity of manufacturing facilities in their 2019 Drug Shortages report. Experienced industry, FDA and academic speakers will present on 1) The background, status and content of ISPE’s industry-for-industry quality maturity framework. This framework has been developed over the past 3 years and evolved from ISPE’s research in response to FDA Quality Metrics draft guidances, and its work to issue the Cultural Excellence report. This program is scheduled to deliver its first module in assessment and potential improvement of CAPA maturity; 2) FDA’s journey to assessing quality management maturity; 3) An academic perspective on how to assess quality maturity

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