Session: Special Topic 2: Quality Management Maturity (QMM) and Metrics: What Does the Future Hold?

Live Q&A (ST2)

Tuesday, September 28, 2021

09:00 – 09:30 EDT

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.

Moderator(s)

CH

Clarice H. Hutchens, PhD, MA, DM

Senior Director
Pfizer
Ballwin, Missouri, United States

Panelist(s)

Denyse D. Baker, PE, RAC

Senior Director of Global Regulatory Policy
AstraZeneca
Gaithersburg, Maryland, United States
Jeff R. Broadfoot, MBA

Senior Director, Quality
Emergent BioSolutions Inc.
Winnipeg, Manitoba, Canada

Regulatory Panelist(s)

AV

Alex M. Viehmann

Division Director, OPQ, CDER
U.S. FDA
Silver Spring, Maryland, United States