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  4. Quality Management Maturity Workshop - 05/24/2022
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Virtual | Virtual

Event Title
Quality Management Maturity Workshop
May 24 - 25, 2022

Date:
May 24 - 25, 2022
Day1:
- ET
Day2:
- ET

Agenda

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Topics & Presentations

Speakers

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

 

Vision of CDER’s QMM Program

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

Drug Shortages: Background and Enduring Solutions

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

QMM, Quality Metrics, and ICH Q12: Do They Complement Each Other?

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

Panel Discussion – Q&A

Valerie Jensen, Ashley Boam

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

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

 

QMM Pilots: CDER’s Lessons Learned

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

QMM Domestic Pilot: Participant Perspective

Nelson Webb
Director
Corporate Quality Assurance
Proctor & Gamble

QMM Foreign Pilot: Participant Perspective

Nuno Matos
Corporate Quality Director
Quality Systems Management
Hovione

Panel Discussion – Q&A

Jennifer Maguire, Nelson Webb, Nuno Matos

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

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

 

CDRH’s Case for Quality

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

Kim Kaplan
Senior Product Manager
ISACA

The Impact of Quality Ratings Systems: Lessons from other Industries

An Economic and Risk Analysis of Quality Ratings and Their Effect on Pharmaceutical Product Market Structure

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

Panel Discussion – Q&A

 

Ron Lear, Kim Kaplan, Clifford Rossi,
Jennifer Maguire and

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

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

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

 

How QMM Ratings Could Inform Drug Purchasing Organizations

Dan Kistner
Group Senior Vice President
Pharmacy Solutions
Vizient

Increasing Resilience of the Drug Supply Chain

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

Panel Discussion – Q&A

 

Dan Kistner, Erin Fox, Ashley Boam, and Adam Fisher
OPQ | CDER

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

Workshop Closing

Michael Kopcha, PhD, RPh
Director
OPQ | CDER

ABOUT THIS WORKSHOP

The FDA is developing a program to assess and rate the quality management maturity (QMM) of facilities manufacturing drug products and active pharmaceutical ingredients. A successful QMM rating program will improve supply chain transparency, inform purchasing decisions, reduce drug shortages, and increase medicine availability.

In Part 1 of this QMM workshop, FDA subject matter experts and guest speakers will:

  • 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

Join us for Part 2 of this QMM workshop in which FDA subject matter experts and guest speakers will:

  • 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

TOPICS COVERED:

Part 1:

  • CDER’s QMM program
  • Drug shortage and pharmaceutical quality
  • QMM, quality metrics, ICH Q12 Lifecycle Management, and advanced manufacturing
  • Lessons learned from QMM pilot programs
  • QMM assessments of pilot program participants

Part 2:

  • CDRH’s existing Case for Quality program
  • Industries with quality ratings systems and their impact
  • Economic and risk analysis of quality ratings and their effect on pharmaceutical market structure
  • How QMM ratings could inform drug purchasers
  • Increasing resiliency of the U.S. drug supply chain

INTENDED AUDIENCE

  • Purchasers of drugs or active pharmaceutical ingredients
  • Pharmaceutical manufacturers
  • International regulators
  • Experts on quality management systems
  • Government agencies involved in the pharmaceutical supply chain
  • Payors and pharmaceutical benefits managers

FDA RESOURCES

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