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/FDA/PQRI Quality Manufacturing Conference workshop discussions. Ask questions on:

  • Clinical Relevance: Implications for Manufacturing
  • Emerging Technologies
  • Innovations in Manufacturing
  • Facilities of the Future
  • Facility and Lifecycle Quality Management
  • Quality Metrics Implementation

Questions submitted so far:

  • Does the FDA recommend specific models for the development of clinically relevant tests and specifications?
  • Please share some successful scenarios for accelerated development products.
  • Are there viable alternate options for the implementation of quality metrics?
  • How are control strategies similar and/or different with traditional vs. new technologies?
  • What are the optimal ways to assure our processes' key parameters remain in a state of control? 
  • Will clinically relevant specifications (CRS) be more relevant over the product lifecycle?

Submit Your Questions or Issues Now »

Facility of the Year Reception & Banquet


Join ISPE and prominent industry leaders as we recognize the 2017 Category Winners for their innovation and creativity in pharmaceutical and biotechnology facility design, construction and operation at the Facility of the Year Awards (FOYA) Banquet on the evening of Tuesday, 6 June 2017 in Arlington, Virginia, USA during the ISPE/FDA/PQRI Quality Manufacturing Conference. The FOYA Awards Banquet is the perfect opportunity to be seen by top pharmaceutical decision makers. Register as an individual or bring a group of your colleagues to honor and support these esteemed winners.

Individual tickets may be purchased during registration for $165.00. For information on sponsorships or to purchase a table of 8, contact:

Alisa Pachella, Account Manager, Sales
Telephone: +1-813-739-2274

Program Committee

Honorary Chairs

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

Regulatory and Industry Planning Team

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
/Linda Evans O'Connor Photograph
Linda Evans O'Connor, PhD, PQRI Co-Chair
Head of Business Processes and Regulatory
Lachman Consultant Services

Add to your Calendar » Register Now »

Event Sponsors

FDA Logo

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/CDER
Office of Pharmaceutical Quality Progress Update
François Sallans Photograph
François Sallans, PharmD
Vice President, Quality & Compliance, Chief Quality Officer
Johnson & Johnson
Quality and Innovation: The Johnson & Johnson Experience
Thomas Cosgrove Photograph
Thomas Cosgrove, JD
Director, Office of Manufacturing Quality
Roger Nosal Photograph
Roger Nosal, PhD
Vice President & Head of Global Chemistry, Manufacturing & Controls, Pfizer Inc.
The New Quality Paradigm
Helen Saccone Photograph
Helen Saccone, PharmD
Associate Director, Global Regulatory Policy
US-EU Mutual Recognition Agreement

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

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