Quality Management Maturity Program 2022 Public Workshop - Part 1 - Session 1

In Part 1 of this Quality Management Maturity (QMM) workshop, FDA subject matter experts and guest speakers:
- Provide a vision of CDER’s QMM program
- Explain the importance of QMM and its potential to improve supply chain decisions and reduce drug shortages
- Discuss the relationship between QMM, quality metrics, ICH Q12 Lifecycle Management, and advanced manufacturing
- Share the perspectives of industry participants in CDER’s QMM pilot programs
- Describe lessons learned from CDER’s QMM pilot programs
00:00 – Vision of CDER’s QMM Program
15:33 – Drug Shortages: Background and Enduring Solutions
28:50 – QMM, Quality Metrics, and ICH Q12: Do They Complement Each Other?
43:15 – Panel Discussion – Q&A


SPEAKERS:

Michael Kopcha, PhD, RPh
Director
Office of Pharmaceutical Quality (OPQ) | CDER

Valerie Jensen, CAPT (Ret.), RPh
Director
Drug Shortage Staff (DSS)
Office of the Center Director (OCD) | CDER

Ashley Boam
Director
Office of Policy for Pharmaceutical Quality (OPPQ)
OPQ | CDER

Panel Discussion Moderator:
Adam Fisher, PhD
Acting Associate Director of Science and Outreach
OPQ | CDER
Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/quality-management-maturity-workshop-05242022

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Видео Quality Management Maturity Program 2022 Public Workshop - Part 1 - Session 1 канала U.S. Food and Drug Administration