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

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 – CDRH’s Case for Quality
27:55 – The Impact of Quality Ratings Systems: Lessons from other Industries
42:45 – An Economic and Risk Analysis of Quality Ratings and Their Effect on Pharmaceutical Product Market Structure
55:10 – Panel Discussion – Q&A

SPEAKERS:

Ron Lear
Director & Chief Architect
IP Development & CMMI Products and Services
CMMI

Kim Kaplan
Senior Product Manager
ISACA

Clifford Rossi, PhD
Executive-in-Residence, Professor of the Practice
Robert H. Smith School of Business
University of Maryland

Francisco (Cisco) Vicenty
Program Manager, Case for Quality
Office of Product Evaluation and Quality
Compliance and Quality Staff
Center for Devices and Radiological Health | FDA

Panel Discussion Moderator:
Neil Stiber, PhD
Associate Director for Science and Communication
OQS | OPQ | CDER


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

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