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Monday, June 25 • 11:00am - 12:15pm
#120: FDA Innovation in Pharmaceutical Quality Assessment and Inspection

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Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-532-L04-P; CME 1.25; IACET 1.25; RN 1.25

FDA’s Office of Regulatory (ORA) and Office of Pharmaceutical Quality (OPQ) within CDER work closely together to provide “one quality for voice” for products including new drugs, biotechnology products, generic drugs, and over-the-counter drugs. Many changes and innovation have occurred since the 2015 stand up of OPQ and the 2017 program alignment within ORA. This session will discuss some of the innovative approaches being used within OPQ and ORA to provide more focused and patient relevant quality assessments, promote review efficiency and innovation for generic drugs and to integrate quality assessment and inspection.`

Learning Objectives

Identify the ongoing FDA initiatives to modernize and integrate the quality assessment and inspection processes for drugs.


Christine M. V. Moore, PhD


Modernization of Quality Assessment of Generic Drugs
Susan M. Rosencrance, PhD

Patient-Focused Quality Within OPQ: Clinically Relevant Specifications and Quality Overall Summary
Ashley Boam, MS

Progress in Integration of Inspection and Quality Assessment
Alonza Cruse

avatar for Ashley Boam

Ashley Boam

Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA, United States
Ashley serves as Director of the Office of Policy for Pharmaceutical Quality in the Center for Drug Evaluation and Research at FDA. OPPQ is responsible for developing and clearly communicating science- and risk-based policies and standards related to drug product quality, including... Read More →
avatar for Alonza Cruse

Alonza Cruse

Director, Office of Pharmaceutical Quality Operations, ORA, OGROP, FDA, United States
Director, Office of Pharmaceutical Quality Operations within FDA’s Office of Regulatory Affairs (ORA), responsible for all pharmaceutical quality inspections & investigations, both foreign & domestic, working in conjunction with FDA Centers: CDER and CVM. Alonza is also leading... Read More →
avatar for Christine Moore

Christine Moore

Executive Director, External Advocacy and Standards, Organon & Co., United States
Christine Moore is a founding member of Organon where she leads Global External Advocacy and Standards, with oversight for new GMP-related policy, analytical standards and compendial affairs. Christine started her career as a process development engineer, after which she moved to... Read More →
avatar for Susan Rosencrance

Susan Rosencrance

Director, Office of Lifecycle Drug Products, OPQ, CDER, FDA, United States
Dr. Susan Rosencrance presently heads FDA's Office of Lifecycle Drug Products within the Office of Pharmaceutical Quality (OPQ). She provides executive leadership by overseeing and directing scientific review programs and activities related to evaluating drug product quality throughout... Read More →

Monday June 25, 2018 11:00am - 12:15pm EDT
Room 206AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  10: RegCMC-Product Quality, Session