FDA’s Quality Management Maturity and Quality Ratings Program

Planning for FDA’s Increased Focus on Quality Management Maturity and Quality Ratings
About the Webinar by
Chris Fanelli, Partner, Sidley Austin LLP
Daniel Roberts, Senior Director, Regulatory Compliance, Sidley Austin LLP

Quality management maturity (QMM) is one of the new buzzwords in FDA’s Office of Pharmaceutical Quality. According to FDA, QMM means is “the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement.”

FDA’s public statements indicate that one of the key objectives of the QMM program is to establish a ratings system that rates manufacturers based on their quality management maturity. According to FDA, a ratings system “will help incentivize drug manufacturers to achieve QMM at their facilities.” With FDA developing its framework for assessing and rating manufacturers based on their QMM, now is the time for manufacturers to understand FDA’s thinking around QMM and quality metrics.
This webinar will feature two former FDA enforcement officials: Chris Fanelli and Dan Roberts of Sidley Austin LLP. Chris and Dan will lead an interactive discussion of FDA’s QMM program, and how manufacturers should be preparing for the implementation of a quality ratings system.