2014 ISPE CGMP Conference
Conference Program
Conference Highlights
Exhibit Hall

2014 ISPE-FDA CGMP Conference

Keynote Speakers

Janet Woodcock, M.D.
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Director, FDA/CDER, USA

Bringing Manufacturing, Science and Quality to the Next Level

Mary Oates, Ph.D.
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Vice President, Global Quality Operations, Pfizer Inc., USA

Implementing and Measuring a Culture of Quality

Gerald Heddell
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Director, Inspection Enforcement & Standards Division, MHRA, UK

European Perspective on Data Integrity

David Smith
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Executive Vice President, Global Operations & IS, AstraZeneca, UK

Approaches in Assuring Reliable Supply from India

Ilisa Bernstein
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Deputy Director, Office of Compliance, FDA/CDER

Global Supply and Emerging Markets

Conference Overview

ISPE is again pleased to co-sponsor a joint conference with the FDA promoting the areas of Quality, Innovation and Technology in the Pharmaceutical industry. The conference has been designed to be of value to Engineers and Scientists working in the areas of: Quality, Product Development, Manufacturing and Regulatory affairs. The selected topics are those that are on the top of the minds of Senior Global Regulators and Industry leaders. The session content has been developed so that individuals with varying years of experience can benefit and contribute to the sessions.

Each day will begin with a Plenary session where senior leaders in the FDA/EMA and industry will present on the topics they feel are most important. The afternoons will be filled with varying interactive sessions allowing the participants to learn and engage with industry experts in three distinct tracks: Quality Systems: Lifecycle from Development to Discontinuation; Data Integrity and Drug Shortages. In addition to the planned presentations, there will be adequate time for individuals to interact with exhibitors and to network with industry peers at planned social activities.

Learning Objectives

As a result of the conference, delegates will...

  • Benefit from direct interaction with FDA and other invited Global regulators..
  • Explore issues and implications of drug supply in our global market.
  • Be equipped to prevent and mitigate drug shortages to assure continued supply to our patients.
  • Contribute and learn what Quality metrics are important to monitor and how to implement them to help monitor your company’s state of control.
  • Be able to anticipate and address challenges inherent in the development process and with products with “Breakthrough” designation including technology transfer, process monitoring and knowledge management.
  • Understand cGMP applicability for maintaining a state of control in combo Drug and Device products, hear the latest on blend and content uniformity, and process validation.
  • Engage with both domestic and European regulators and industry experts regarding current experiences and expectations for data integrity.
  • Be aware of current legal, laboratory, inspection and compliance issues in data integrity.
  • Gain insights into the development of a corporate data integrity program that addresses the entire computer system lifecycle.
  • Commit to addressing ethics issues related to data integrity.
  • Interact with global suppliers providing services and support to ensure quality throughout the lifecycle.

Register Early

Register before 9 May 2014 to save! Discounted rates apply for groups of 3 or more.

Facility of the Year Awards (FOYA) Banquet

FOYA Logo

In addition to the Conference, the prestigious Facility of the Year (FOYA) Awards Banquet will be held on 3 June in conjunction with this event.

CMO Executive Workshop to Follow CGMP!

KEYNOTE SPEAKERS CONFIRMED!

JANET WOODCOCK, MD, Director, FDA/CDER, USA

Bringing Manufacturing, Science and Quality to the Next Level

MARY OATES, PhD, Vice President, Global Quality Operations, Pfizer Inc., USA

Implementing and Measuring a Culture of Quality

DAVID SMITH, Executive Vice President, Global Operations & IS, AstraZeneca, UK

Approaches in Assuring Reliable Supply from India

ILISA BERNSTEIN, PHARM D, JD,, Deputy Director, Office Compliance, FDA/CDER, USA

Global Supply and Emerging Markets

GERALD HEDDELL, Director, Inspection Enforcement & Standards Division, MHRA, UK

European Perspective on Data Integrity

MEET OUR PROGRAM COMMITTEE!

Mike Arnold, Senior Director, Strategic Partnerships, Pfizer Global Clinical Supplies, USA

David Doleski, Director, Division of DGMPA, FDA

Joe Famulare, VP, Global Compliance and External Collaboration , Pharma Technical Quality, Genentech Inc., USA

Rick Friedman, Associate Director, Office of Manufacturing & Product Quality, FDA

Brian Hasselbalch, Consumer Safety Officer, CDER, FDA

Charles Hoiberg, Executive Director, Pfizer Inc., USA

Steve Lynn, Director, Office of Manufacturing and Product Quality, FDA

George Millili, Senior Principal Technical Advisor, Genentech Inc., USA

Mike Smedley, Deputy Director, Office of Compliance, FDA