SBIA | Again today - Quality Management Maturity Workshop

Join us today at 1PM ET for Part 2

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance WORKSHOP Quality Management Maturity Workshop Date: May 25, 2022 Day 2: Wed, May 25, 1:00 PM - 4:00 PM ET This webinar is FREE. Register Agenda Join Live Stream Link for  Webcast Download Slides 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. 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.  FDA Voices Blog 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 SBIA Webinar: FDA Announces Quality Management Maturity Programs Drug Shortages: Root Causes and Potential Solutions The White House's 100 Day Supply Chain Review Report OPQ's 2021 Annual Report Report on the State of Pharmaceutical Quality Pharmaceutical Quality Resources CDER Quality Management Maturity Quality Metrics for Drug Manufacturing OPQ White Paper for Quality Management Maturity 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. Register for Upcoming Training Watch Learning Library Recordings on YouTube Subscribe to CDER SBIA Email Updates Follow on LinkedIn Follow on Twitter

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