Learning Tracks

The Future of Quality and the Supply Chain

Tuesday, October 3, 2023

1:15 p.m. - 2:30 p.m.

Regulators are increasingly looking for ways to assure the supply of high-quality, safe, and effective drugs in their markets. This session will explore possible solutions that may have the effect of improving both the quality and supply of generic and biosimilar medicines, including Quality Management Maturity (QMM), advanced manufacturing, and processes and policies related to inspections and surveillance.

Speakers:

CAPT Tara Gooen Bizjak, MS
Director, Manufacturing, Guidance and Policy Staff for Pharma Compliance at OC, CDER, FDA

Christina Mazzella, M.S.
Vice President, Global Quality Compliance, Teva Pharmaceuticals

Mayank Nagar, M.S., M.B.A.
Vice President & Head – Tech Services & New Product Launch, Dr. Reddy’s Laboratories Inc.

Alex Viehmann, BS
Division Director, Division of Quality Intelligence II, OQS, OPQ, CDER, FDA

Joel Welch, PhD
Associate Director for Science and Biosimilar Strategy, OB, OPQ, CDER, FDA

Lillian Hua Zhang, PhD
Branch Chief, Division of Internal Policies and Programs, OPPQ, OPQ, CDER, FDA

Panelist:

Dennis Hall
Vice President, Advanced Manufacturing Technologies, U.S. Pharmacopeia