PDA's Pharmaceutical Quality System (ICH Q10) Conference

PAREXEL Panelist: (Session and panel details below)

David L. Chesney
Vice President
Strategic Compliance
PAREXEL Consulting

Tuesday, October 4th, 10:45 a.m. – 12:30 p.m.

P2: Pharmaceutical Quality Management System - Continued

Moderator: Anders Vinther, PhD, Vice President, Quality Biologics, Genentech

Session Description: Why is a strong Quality System so fundamental to achieving and maintaining operational excellence? What can we learn from other industries? What are the cost benefits of more effective and efficient manufacturing? In the opening session, senior leaders will discuss how the industry and consumers benefit when science-based risk management is used throughout the lifecycle to assure a robust state of control. The session will address the tangible quality-business synergy reaped by "learning organizations" who proactively seek out sources of variability through daily vigilance and take advantage of contemporary technological solutions to improve product quality.

10:45 a.m. – 11:15 a.m.

U.S. Regulatory Perspectives
Richard L. Friedman, Associate Director, Office of Manufacturing and Product Quality (acting), CDER/OC, FDA

11:15 a.m. – 11:45 a.m.

European Regulatory Perspectives
David Cockburn, Head of Manufacturing and Quality Compliance, European Medicines Agency (EMA)

11:45 a.m. – 12:30 p.m.

Panel Discussion
Richard Bowles III, PhD, Merck & Co., Inc.
David Chesney, PAREXEL Consulting
David Cockburn, EMA
Richard L. Friedman, FDA
Jeffrey Macher, Georgetown University

For a complete agenda and details, please visit the event web site.