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Clarice Hutchens, PhD, MA, DM
Senior Director
Pfizer
Ballwin, Missouri, United States
Denyse Baker, PE, RAC
Senior Director of Global Regulatory Policy
AstraZeneca
Gaithersburg, Maryland, United States
Jeff Broadfoot, MBA
Senior Director, Quality
Emergent BioSolutions Inc.
Winnipeg, Manitoba, Canada
Denyse Baker, PE, RAC
Senior Director of Global Regulatory Policy
AstraZeneca
Gaithersburg, Maryland, United States
Alex Viehmann
Division Director, OPQ, CDER
U.S. FDA
Silver Spring, Maryland, United States
Hear latest update from CDER/OPQ on their QMM and Metrics programs. PDA’s Quality Management Maturity Task Force has built upon prior PDA research to assess the top QMM elements for FDA consideration in their QMM program. PDA’s Quality Culture Assessment Tool standards team will share a sneak peek of the public draft of the standard being released for peer review this fall. This session will begin with a brief update on PDA’s QMM initiatives with their recommendations on which QMM elements are important for FDA to consider in developing an assessment model. FDA OPQ will present a brief status of the QMM Pilot and their future metrics and QMM plans. A prepared interview with FDA and industry panelists will follow with time for audience Q&A at the end.
Presenter: Denyse D. Baker, PE, RAC – AstraZeneca
Regulatory Presenter: Alex M. Viehmann – U.S. FDA
Moderator: Clarice H. Hutchens, PhD, MA, DM – Pfizer
Panelist: Denyse D. Baker, PE, RAC – AstraZeneca
Panelist: Jeff R. Broadfoot, MBA – Emergent BioSolutions Inc.
Regulatory Panelist: Alex M. Viehmann – U.S. FDA