Recording Overview

Are you aware of the cost of poor quality to your company?  If you are a leader or decision maker in a pharmaceutical manufacturing business and want to maintain a sustainable business and you have missed the 2011 Pharmaceutical Quality System (ICH Q10) Conference, you now have the opportunity to listen to the conference recordings.

Dedicated to teaching the principles of ICH Q10, these recordings will provide a unique opportunity to learn principles from companies that have implemented a Pharmaceutical Quality System across the product lifecycle according to the ICH Q10 model.  Companies as such are reaping the benefits that come from establishing and maintaining a state of control, continual improvement, enhancing regulatory compliance and meeting quality objectives every day.

ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the product lifecycle.  While these recordings are intended to explain the principles of ICHQ10 it does not only states what ICH Q10 says.  The recordings will provide an opportunity where one can learn the practicalities of how to implement Q10 based on real-life case studies and will show how senior management commitment and involvement is vital.

Target Audience

If you are a decision-maker at mid-level or senior level, or a professional working at site or corporate level in the following areas you should attend:

• Quality Assurance
• Manufacturing, Operations and Engineering
• 6-sigma and Quality Risk Management
• Supply chain
• Pharmaceutical Development and CMC
• Regulatory Affairs

Recorded Sessions and Presenters

Pharmaceutical Quality System
Steven Lynn, MS, Director (acting), Office of Manufacturing and Product Quality, CDER/OC, FDA
Richard Bowles III, PhD, Executive Vice President  & Chief Ethics and Compliance Officer, Merck & Co., Inc.
Jeffrey Macher, PhD, Associate Professor, Robert E. McDonough School of Business, Georgetown University
G.K. Raju, PhD, CEO, Light Pharma, Inc.   
Richard L. Friedman, Associate Director, Office of Manufacturing and Product Quality (acting), CDER/OC, FDA
David Cockburn, Head of Manufacturing and Quality Compliance, European Medicines Agency (EMA)

Management Responsibility
Ian Thrussell, Expert, Senior Inspector GMP, Medicines and Healthcare Products Regulatory Agency (MHRA)
Anders Vinther, PhD, Vice President, Quality Biologics, Genentech          
Ron Stellon, Vice President, Quality Assurance, Americas Region, AstraZeneca Pharmaceuticals
Mary Oates, PhD, Vice President, Global Quality Operations,  Pfizer
Janeen Skutnik-Wilkinson, Director, Quality and Regulatory Policy, Pfizer

Lifecycle Goals
Christine Moore, PhD, Deputy Director for Science and Policy, OPS/ONDQA, FDA
Georges France, PhD, Vice President of Quality Strategy, Pfizer
George Millili, PhD, Senior Director, Pharmaceutical Commercialization Development, Merck Manufacturing Division, Merck & Co., Inc.
Kevin O’Donnell, PhD, Market Compliance Manager, Irish Medicines Board (IMB)

Quality System Enablers: Knowledge Management and Quality Risk Management
Marty Lipa, Director, Knowledge Management Leader, Global Science, Merck & Co., Inc.
Stephen Liebowitz, PhD, Group Director, Global Regulatory Science, Bristol-Myers Squibb
Tara Gooen, Team Leader for New and Generic Manufacturing Team, CDER, FDA

Establishing and Maintaining a State of Control
Grace McNally, Team Leader, Guidance and Policy (acting), CDER, FDA
Joanne Barrick, Advisor, Global Validation Support, Eli-Lilly & Company
John McShane, Director of Validation, Genentech

Pharmaceutical Quality System Elements: Process Performance and Product Quality Monitoring System
Georges France, PhD, Vice President of Quality Strategy, Pfizer
Deborah Baly, Senior Director, Genentech
Process Capability Measurement
Lynn Torbeck, Statistician, Torbeck and Associates

Pharmaceutical Quality System Elements: Continual Improvement of the Process (CAPA)
Martin VanTrieste, Senior Vice President of Quality, Amgen
Juan Andres, Head of Quality, Novartis International AG   
Jeff George, CEO, Sandoz

Change Management
Robert Hughes, Program Director, Astra Zeneca
Bernadette Doyle, PhD, Vice President, Technical Head, Global Manufacturing and Supply, GlaxoSmithKline

Continual Improvement of the Pharmaceutical Quality System
Erin McCaffery, Investigator, Pharmaceutical Inspectorate, ORA, FDA
Zena Kaufman, Division Vice President, Abbott Laboratories
Frank Deane, PhD, President, Manufacturing, Eli Lilly & Company

Registration contact

Jason E. Brown
Senior Programs Manager
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093
Email: brown@pda.org