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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

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been:

  • pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area
  • pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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