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