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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