2014 ISPE CGMP Conference

Conference Highlights


Quality Systems: Lifecycle from Development to Discontinuation

  • FDA on Manufacturing Science and Quality
  • Industry on Implementing and Measuring a Culture of Quality
  • Metric Implementation - Beyond just talk!
  • TRACK 1:Challenges of Development: Anticipating Your Process
    • Tech Transfer
    • Knowledge Management
    • Breakthrough Therapies
  • TRACK 2: Maintaining a State of Control
    • Combo Products
    • Blend and Content Uniformity - See: FDA Q & A
    • Process Validation including an extra night session

Data Integrity

  • FDA perspective on current inspection and compliance issues
  • Legal aspects of data integrity
  • Data integrity in the laboratory
  • Auditing manufacturing operations
  • Corporate programs, lifecycle and ethics considerations

Drug Shortages - A Joint Session with CMO Executive Workshop Attendees

  • FDA, MHRA, Industry to discuss preventing and mitigating drug shortages
  • Join FDA, CMOs, Owner Companies attending the CMO Executive Workshop for a dynamic interaction!
  • Hear the latest on implementing drug shortage recommendations

Bonus Sessions

  • Breakfast with the Inspectors is back by popular demand! Wednesday 4 June 07.00-08.00
  • Breakfast Session on Assessing Blend and Content Uniformity – Tuesday 3 June 07.00-08.00
  • Evening Session on Process Validation Monday 2 June 19.00-2030


  • Take full advantage of this laboratory of ideas to benefit your company.
  • Exhibits available throughout both conference days and on Monday evening!
  • Experience a broad scope of suppliers providing products and services in support of your quality initiatives.
  • Don’t Forget! Bring Business Cards for the Networking Events in the Exhibit Hall!

FOYA Reception and Banquet FOYA Logo

2014 Facility of the Year Category Winners to Assemble!

Join ISPE and prominent industry leaders as we recognize the 2014 Category Winners and look back on 10 years of leading technological innovation in pharmaceutical and biotechnology facility design, construction and operation with a brand new gala celebration, the Facility of the Year Awards (FOYA) Banquet.

Join us for the CMO Executive Workshop!

  • Official Kick-Off begins after Joint Drug Shortage Session Wednesday morning
  • Participate in 2 days of high-level discussions around CMO challenges and expectations




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