ISPE/FDA/PQRI Quality Manufacturing Conference, 5-7 June, Marriott Crystal Gateway Hotel, Arlington, VA

5th Annual
ISPE/FDA/PQRI Quality Manufacturing Conference
Align Company Strategies with Regulatory Priorities

The FDA Office of Pharmaceutical Quality has identified its top priorities for 2017
Will your company be in sync?

Don't miss this opportunity to interact directly with industry and regulatory leaders to identify real solutions to your company's challenges on key issues. Sessions will be designed around open discussion on current FDA priorities and industry-critical quality initiatives.

  • Linking Quality to Clinical Relevance
  • Modernizing Pharmaceutical Manufacturing through Emerging Technology and Innovation
  • Designing Proactive Approaches to Facility and Lifecycle Quality Management
  • Implementing Next Steps for Quality Metrics

Tired of listening to talk after talk? Want your voice to be heard? 

Expect a different kind of conference!

Have a Question for Industry and Regulatory Leaders?

Get your questions or issues addressed during the 2017 ISPE/PQRI Quality Manufacturing conference workshop discussions.  Questions and issues that have been submitted:

  • Clinical Relevance: Implications for Manufacturing
  • Emerging Technologies
  • Innovations in Manufacturing
  • Facilities of the Future
  • Facility and Lifecycle Quality Management
  • Quality Metrics Implementation
  • Does the FDA recommend specific models for the development of clinically relevant tests and specifications?

What questions or issues do you have? Submit Them Now »

Program Committee

Honorary Chairs

/Michael Kopcha Photograph
Michael Kopcha, PhD, RPh
Director, Office of Pharmaceutical Quality
FDA
/François Sallans Photograph
François Sallans, PharmD
VP Quality & Compliance, Chief Quality Officer
Johnson & Johnson

Committee Members

George Millili Photograph
George Millili, PhD, Industry Chair
Senior Principal Technical Advisor
Genentech (A member of the Roche group)
/Timothy Watson Photograph
Timothy Watson, PhD, Industry Co-Chair
Research Fellow / CMC Advisory Office
Pfizer Inc.
Rapti Madurawe Photograph
Rapti Madurawe, PhD, FDA Co-Chair
Director (Acting)
Division of Process Assessment I
FDA
/Linda Evans O'Connor Photograph
Linda Evans O'Connor, PhD, PQRI Co-Chair
Director
Lachman Consultant Services

Add to your Calendar » Register Now »


Event Sponsors

FDA Logo
PQRI Logo

Early Registration Discount
Ends 24 April 2017! 

Keynote Speakers
Industry and FDA Leaders on the Status of Quality Manufacturing

Michael Kopcha Photograph
Michael Kopcha, PhD, RPh
Director, Office of Pharmaceutical Quality
FDA
François Sallans Photograph
François Sallans, PharmD
Vice President, Quality & Compliance, Chief Quality Officer
Johnson & Johnson

Join ISPE today and save hundreds of dollars on registration as well as enjoy other great membership benefits.

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Presentations & Attendee Roster

Conference Attendees: