2014 ISPE CGMP Conference

Networking Opportunities

Continue the conversation with colleagues and presenters.
FDA Experts, Industry Leadership & Exhibitors!

  • Welcome Reception for all Delegates, Leaders and Speakers on Monday, 2 June 2014 from 17.00 to 18.30 in the Exhibit Hall.
  • FOYA Banquet for all Facility of the Year Category Winners on Tuesday, 3 June 2014 at 18.30.
  • Don't Miss these Breakfast Sessions
    • Back by Popular Demand!  Breakfast with the Inspectors - Wednesday 4 June 07.00-08.00
    • Assessing Blend and Content Uniformity - Tuesday 3 June 07.00-08.00
  • Bonus evening session on Process Validation - Monday 2 June 19.00-20.30
  • Structured Break-out Discussions on topics ranging from quality issues and initiatives to quality metrics implementation to drug shortage solutions.
  • Networking Breaks and shared meals throughout the conference.

***Bring your business cards!

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