Quality Management Maturity Program 2022 Public Workshop - Day 2 - Session 2

In Part 2 of this Quality Management Maturity (QMM) workshop, FDA subject matter experts and guest speakers:
- Describe how quality ratings have positively impacted medical device manufacturers through CDRH’s
- Case for Quality program
- Discuss existing quality ratings programs and their impact on industries
- Present research on financial and other risks associated with QMM ratings
- Provide perspectives from academia and industry on the importance of QMM
- Share opportunities for stakeholders to use QMM ratings
- Discuss perspectives of impacted stakeholders

00:00 – How QMM Ratings Could Inform Drug Purchasing Organizations
20:45 – Increasing Resilience of the Drug Supply Chain
44:20 – Panel Discussion – Q&A
1:12:30 – Workshop Closing

SPEAKERS:

Dan Kistner
Group Senior Vice President
Pharmacy Solutions
Vizient

Erin R. Fox, PharmD, BCPS
Senior Pharmacy Director
University of Utah Health

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

Adam Fisher, PhD
Acting Associate Director of Science and Outreach
OPQ | CDER

Michael Kopcha, PhD, RPh
Director
OPQ | CDER

Panel Discussion Moderator:
Kristin Phucas
Associate Director for Communication
Office of Policy for Pharmaceutical Quality (OPPQ) | OPQ | CDER

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

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