Virtual

Event Title

Quality Management Maturity Workshop

May 24 - 25, 2022

Date:: May 24 - 25, 2022
Day1:: Tue, May 24 1:00 PM - 4:00 PM ET
Day2:: Wed, May 25 1:00 PM - 4:00 PM ET

Attend

Visit CDER Small Business and Industry Assistance Page

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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