2014 ISPE CGMP Conference

Education Program

2014 ISPE-FDA CGMP Conference

ISPE and the FDA proudly present the 3rd Annual CGMP Conference
Quality Systems - Data Integrity
Metrics Implementation - Combo
Products - Drug Shortages

Are Your Quality Systems Robust, Reliable, Secure?

  • Is your supply at risk? How can you do better business with emerging partners?
  • Do you have confidence in your process development strategies?
  • Do you truly know your process from development through discontinuation?
  • Are risk assessments in place to verify your decisions?

No other event drives critical conversations forward like the CGMP Conference. Network with FDA and industry leaders, hear proven lessons and gain insights to help you and your company ensure robust end-to-end control of your processes and Quality Systems.

Be Proactive - Anticipate Your Process!  Learn from ISPE and FDA!

  • Data Integrity: Fraud. Risk. What is really important?
  • Combo Products: Following Combo Rules? Are you ready?
  • Beyond Data: Readiness for Manufacturing. Maintaining a State of Control.
  • Drug Shortages: Root cause to Preventative Actions




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


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

Thomas Cosgrove, JD, Director, Office of Manufacturing and Product Quality, FDA

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

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

Mike Smedley, Deputy Director, Office of Compliance, FDA