Friday, April 29, 2022

SBIA | Quality Management Maturity Workshop

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CDER SBIA Webinar Registration

FDA | CDER | Small Business and Industry Assistance

WORKSHOP

Date: May 24 - 25, 2022
Day 1:  -  ET
Day 2:  -  ET

This webinar is FREE.

Register

Agenda

ABOUT THIS WEBINAR

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.

CDER's Office of Pharmaceutical Quality (OPQ) released a whitepaper on Quality Management Maturity (QMM). To increase transparency and incentivize investment in mature quality management practices, CDER is developing a framework to objectively rate the QMM of pharmaceutical manufacturing sites.

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

This webinar is part of the SBIA Regulatory Education for Industry (REdI) series.

TOPICS

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

 


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