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
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
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 is:
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.
The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
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