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Wednesday, June 29 • 10:30am - 11:45am
#321: Office of Pharmaceutical Quality Update

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Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-606-L04-P; CME 1.25; IACET 1.25; RN 1.25

The formation of the Office of Pharmaceutical Quality (OPQ) is a milestone in FDA efforts to assure the quality and availability of medicines to the public. OPQ's motto of "One Quality Voice" is manifested in the organizational construct that provides functional expertise but enables a team approach to regulatory review and inspection. This session will outline current status and ongoing initiatives underway in OPQ and will provide the audience with access to selected OPQ senior leadership.

Learning Objectives

Discuss current updates on initiatives and implementation strategies for the Office of Pharmaceutical Quality (OPQ); Identify additional information regarding forthcoming activities in OPQ.


Robert Iser, MS


Michael Kopcha

Lawrence X. Yu, PhD

avatar for Robert Iser

Robert Iser

Acting Director, Office of Process and Facilities, OPQ, CDER, FDA
Bob joined the FDA in 2003. He is currently the acting Director of the Office of Process & Facilities. Prior to the formation of OPQ, Bob was acting Associate Director for Policy Development in OPS. He was also a Division Director and CMC Team Leader in OGD. Prior to joining the FDA... Read More →

avatar for Michael Kopcha

Michael Kopcha

Director, Office of Pharmaceutical Quality, CDER, FDA
With more than 25 years of pharmaceutical industry experience, Dr. Kopcha’s areas of expertise include formulation and process development, process validation, technology transfer, off-shoring/outsourcing, and change management. Before joining FDA, Dr. Kopcha served as vice president... Read More →
avatar for Lawrence Yu

Lawrence Yu

Deputy Director, Office of Pharmaceutical Quality, CDER, FDA
Dr. Lawrence X. Yu is the Deputy Director for Science and Director of Chemistry at the Office of Generic Drugs, Food and Drug Administration, overseeing CMC review operation, policy development, and regulatory research with over 140 staff scientists. He is also adjunct Professor of... Read More →

Wednesday June 29, 2016 10:30am - 11:45am EDT
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 12: Pharm Quality, Forum