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10:30am EDT

#321: Office of Pharmaceutical Quality Update

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.

Chair

Robert Iser, MS

Speaker

Panelist
Michael Kopcha

Panelist
Lawrence X. Yu, PhD

Chair

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 →

Speakers

Michael Kopcha

Director, Office of Pharmaceutical Quality, CDER, FDA, United States

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 →

Lawrence Yu

Director, Office of New Drug Products, OPQ, CDER, FDA, United States

Lawrence X. Yu, Ph.D., is the Director, Office of New Drug Products, Food and Drug Administration and Rapporteur, ICH M4Q(R2) Expert Working Group. Dr. Yu is also an adjunct Professor at the University of Michigan. Dr. Yu is an Associate Editor of the AAPS Journal. Dr. Yu has authored/co-authored... 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

Credit Type ACPE, CME, IACET, RN
Audience Intermediate
Featured Topics Agency Participation
Interest Area Regulatory Affairs, CMC-GMP
format json
Interest Area Regulatory Affairs,CMC/GMP
Featured Topics Agency Participation
Credit Type ACPE, CME, IACET, RN
Tags Forum