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

Unprecedented Access for Open Conversations with FDA Regulators!

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  • Thomas Cosgrove, JD, Director, Office of Manufacturing Quality, FDA/CDER/OC
  • Richard Friedman, Deputy Director, Science and Regulatory Policy, FDA/CDER/OC/OMQ
  • Michael Kopcha, PhD, RPh, Director, Office of Pharmaceutical Quality, FDA/CDER
  • Rapti Madurawe, PhD, FDA Co-Chair, Director (Acting) Division of Process Assessment I, FDA/CDER/OPQ
  • Jennifer Maguire, PhD, Division Director (Acting), Office of Surveillance, FDA/CDER/OPQ
  • Sarah Pope Miksinski, PhD, Director, Office of New Drug Products; Director (Acting), Office of Surveillance, FDA/CDER/OPQ
  • Helen Y. Saccone, PharmD, Associate Director, Global Regulatory Policy, FDA/OC/OGROP
  • Sharmista Chatterjee, PhD, Division Director, Office of Process and Facilities and Emerging Technology Team Member, FDA/CDER/OPQ/DPAII
  • Paul Seo, PhD, Director (Acting), Division of Biopharmaceutics, FDA/CDER/OPQ/ONDP
  • Rakhi Shah, PhD, Branch Chief (Acting), Office of Process & Facilities, FDA/CDER/OPQ

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2017 ISPE/FDA/PQRI Quality Manufacturing Conference Brochure

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:

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

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Event Sponsors

Industry and Regulatory Experts to Discuss These Questions and More!

  • Could the concepts behind continuous process verification be similarly applied to maintain qualified state?
  • How can lifecycle quality management concepts be applied to Legacy products?
  • What major components are essential to establish a reliable state of process controls?
  • How much data is required to ensure that process is in state of control?
  • What are some successful scenarios for accelerated development products?
  • How can companies ensure a successful PAI on a new technology?
  • Should clinical studies be designed to include variability in product?
  • What validation variations are inherent with respect to sterile and non-sterile environments?
  • Are there viable alternate options for the implementation of quality metrics?
  • What are the key factors in managing control strategies for emerging technologies?
  • How and when are quality attributes defined as “critical”?
  • What are the most meaningful and predictive metrics?
  • Is FDA and MHRA approval required for manufacturing New Chemical Entity (NCE) or New Drug substance meant for clinical trials?

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Keynote Speakers

Helen Saccone Photograph
US-EU Mutual Recognition Agreement
Helen Saccone, CDR, PharmD
Associate Director, Global Regulatory Policy
Michael Kopcha Photograph
Office of Pharmaceutical Quality Progress Update
Michael Kopcha, PhD, RPh
Director, Office of Pharmaceutical Quality, FDA/CDER
Thomas Cosgrove Photograph
Outsourcing Quality: Perspectives on Risk in the Global Drug Supply Chain
Thomas Cosgrove, JD
Director, Office of Manufacturing Quality
François Sallans Photograph
Quality and Innovation: The Johnson & Johnson Experience
François Sallans, PharmD
Vice President, Quality & Compliance, Chief Quality Officer
Johnson & Johnson
Roger Nosal Photograph
The New Quality Paradigm
Roger Nosal, PhD
Vice President & Head of Global Chemistry, Manufacturing & Controls, Pfizer Inc.
Brian Boyd Photograph
Facility Management Past, Present, and Future: Transforming with the Times
Brian Boyd
Vice President, Global Facilities Management
Johnson & Johnson

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