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Thank you for attending the 2016 ISPE/FDA/PQRI Quality Manufacturing Conference. The conference provided an avenue for regulators and industry to collaborate on innovations in pharmaceutical manufacturing and an opportunity to network in a stimulating learning environment. Hear what attendees had to say.

“I particularly enjoyed the emerging technologies presentations (continuous modular manufacturing, 3D printing, next wave medical devices, etc.). The back-and-forth between FDA representatives and industry was great; a rare opportunity!”

“Dr. Yorum Unguru speaking on ethical dilemmas of drug shortages was excellent. Tying an industry topic (drug shortages due to quality issues) back to its real world impact made a powerful impact.”

“I was impressed by the quality of the FDA keynote speeches demonstrating new leadership and vision within the FDA.“

Highlights from the Conference

Attendees were given front row access to some of the most influential quality manufacturing speakers and regulators from the pharmaceutical industry.  During the conference, attendees received exclusive access to the Quality Metrics Wave 2 Report.  Learn more about how this report will enable a continued data-driven dialogue with the FDA for years to come.

Conference Photograph 1 Conference Photograph 6

ISPE and prominent industry leaders recognized the 2016 Facility of the Year (FOYA) Category Winners for their innovation and creativity in pharmaceutical and biotechnology facility design, construction, and operation at the Facility of the Year Awards Reception & Banquet.  In addition to recognizing the 2016 Category Winners, Baxter BioPharma Solutions and Jannsen Vaccines AG were recognized for their exceptional leadership in Drug Shortage Prevention.  Learn about what these two companies have done to strengthen their ability to prevent drug shortages.

Conference Photography 3 - FOYA Awards Conference Photography 4 - FOYA Award

Sessions were packed with attendees as they heard from speakers on four engaging tracks including Manufacturing and Operational Excellence, Transformation of Quality Oversight, Frontiers in Manufacturing Science and Quality, and Quality Metrics.  Check out the sound bites from each of these tracks.

Conference Photography 5 Conference Photograph 2

Thank You to Our Program Committee!

FDA Co-Chair: Lawrence Yu, PhD, Deputy Director, Office of Product Quality, FDA

Industry Co-Chair: Peter Carbone, Vice President, Global Head External Relations, Group Quality, Novartis Pharmaceuticals

PQRI Co-Chair: Louis Yu, PhD, Executive Vice President, Retired, Perrigo; PQRI Board Treasurer

Track Leaders

Manufacturing and Operational Excellence

  • David Doleski, Deputy Director (Acting), Office of Process & Facilities, FDA/CDER/OPQ/OPF
  • Rick Friedman, Deputy Director, Science and Regulatory Policy, FDA/CDER/OC/OMQ
  • Cynthia Harris, Head of Manufacturing Science & Technology, Novartis-Alcon
  • Louis Yu, PhD, Executive Vice President, Retired, Perrigo; PQRI Board Treasurer

Transformation of Review/Inspection Quality Oversight

  • Alonza Cruse, Orange County, California Area - Director, (Acting), Office of Medical Products & Tobacco Operations, FDA/ORA/OMPTO
  • Rose Mary Dollard, Director, Regulatory Compliance Johnson & Johnson
  • Karen Hirshfield, RPh, Senior Compliance Specialist, Genentech/Roche
  • Robert Iser, Director (Acting), Office of Process & Facilities, FDA/CDER/OPQ/OPF
  • Lorraine McClain, Senior Director, Quality Risk Management, Teva Pharmaceuticals

Frontiers in Manufacturing Science and Quality

  • Tom Garcia, PhD, Research Fellow, Pfizer Inc.
  • Theodora Kourti, PhD, Senior Vice President, Global Regulatory Affairs, ISPE
  • Sau (Larry) Lee, PhD, Associate Director for Science, Chair for OPQ Emerging Technology Team, FDA/CDER/OPQ
  • Neil Stiber, PhD, Deputy Director (Acting), Office of Surveillance, FDA/CDER/OPQ/OS

Event Sponsors

Exclusive Attendee Downloads:

Conference handouts »
Attendee roster »

Quality Metrics Wave 2 Report Instructions:

• Log in to your ISPE profile
• Go to "My Downloads"
• Select download for each quality metrics tool


Save the Date for 2017

The 2017 Quality Manufacturing Conference will be held in Arlington, VA on 5 — 7 June 2017. Sign-up to receive notifications about the conference including when registration opens and early bird pricing.