Quality Management Maturity Program 2022 Public Workshop - Part 1 - Session 2

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 – QMM Pilots: CDER’s Lessons Learned
28:20 – QMM Domestic Pilot: Participant Perspective
44:50 – QMM Foreign Pilot: Participant Perspective
1:00:35 – Panel Discussion – Q&A


SPEAKERS:

Jennifer Maguire, PhD
Director
Office of Quality Surveillance (OQS)
Office of Pharmaceutical Quality (OPQ) | CDER

Nelson Webb
Director
Corporate Quality Assurance
Proctor & Gamble

Nuno Matos
Corporate Quality Director
Quality Systems Management
Hovione

Panel Discussion Moderator:
Lyle Canida, Pharm.D.
Acting Associate Director of Science and Outreach
Regulatory Operations Officer | OPQ | CDER

Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/quality-management-maturity-workshop-05242022

-------------------- 
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.   

Upcoming Training - https://www.fda.gov/cdersbia
SBIA Listserv - https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2022 Playlist - https://www.youtube.com/playlist?list=PLey4Qe-UxcxbzCGn90m38cXN2DL2i3VmD
SBIA LinkedIn - https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources - https://www.fda.gov/cdersbialearn
Twitter - https://twitter.com/FDA_Drug_Info
Email - [email protected]
Phone - (301) 796-6707 I (866) 405-5367