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Conference Recap

Conference Session Photograph

A look back at another exciting Quality Manufacturing Conference.

“The program was wonderfully designed.”

“Thank you for providing comprehensive educational sessions”

“The keynotes were great, it was nice to see industry and FDA saying the same thing.”

“We found the conference sessions as well as the side-bar conversations with members extremely valuable!“

Celebrating its fourth year, ISPE/FDA/PQRI Quality Manufacturing Conference hosted officials from FDA and top industry leaders, who led discussions and workshops on pharmaceutical quality that helped advance industry thinking on hot topics like: Continuous Manufacturing, Modernization and Production Efficiency, Drug Shortage Prevention, Risk Management, Robust Change Management and Using Operational Excellence as a Foundation for Quality.

If you weren’t able to join us in Washington, DC this year, make sure to join us on 6 – 8 June 2016 in Bethesda, MD at the Marriott North for the 5th Annual ISPE/FDA/PQRI Quality Manufacturing Conference.

Here’s a look at what you missed.

Keynote Speakers

Monday’s keynotes set the tone of the whole conference with key quality manufacturing messages.

Juan Andres Photograph

Juan Andres, Head Pharma TechOps, Novartis Pharma AG
Innovative Manufacturing Promotes Quality

“The pharmaceutical industry must create a culture of quality beyond compliance by making supply, quality, and efficiency work together.”
Janet Woodcock Photograph

Janet Woodcock, MD, Director, FDA/CDER
FDA Quality Initiatives

“We must resolve the problems of the past and turn to the opportunities of the future—and there are many. Quality metrics will be a big part of the answer.”

Tuesday morning, Christine Moore and Andy Skibo encouraged the audience to question the risk within their own supply chain.

Christine Moore Photograph

Christine Moore, Acting Director, Office of Process and Facilities, FDA/CDER/OPQ/OPF
Supply Chain Risk Management

Andy Skibo Photograph

Andrew Skibo, Head of Global Biologics Operations & Global Engineering, MedImmune/AstraZeneca
Supply Chain Risk Management

Wednesday, Thomas Cosgrove led a full day of programming dedicated to Regulatory issues.

Thomas Cosgrove  Photograph Thomas Cosgrove, JD, Director, Office of Manufacturing Quality, Office of Compliance, FDA/CDER/OC/OMQ

Breakout Sessions

The breakout sessions focused on 3 key areas: Manufacturing Innovations, Quality Systems Advances and Regulatory Insights. Sessions included presentations such as these:

  • ISPE Quality Metrics Initiative Update - Diane Hagerty, Vice President, Genentech Inc, USA
  • Continuous Pharmaceutical Manufacturing: Quality-by-Design, Systems Integration, and Control - Richard Braatz, PhD, Edwin R. Gilliland Prof of Chemical Engineering, Novartis-MIT Center for Continuous Manufacturing, USA
  • Continual Improvement - Cpks in Action - Georgina McLeod, PhD, Principle Process Development Engineer, AbbVie, USA
  • Delivering Breakthrough Therapies to the Market with Continuous Manufacturing and Real Time Release - Hayden Thomas, Vice President, Formulation Development, Vertex Pharmaceuticals, Inc., USA
  • Driving Process Performance through Awareness and Proactive Response - Jenn Walsh, Associate Director Technical Services, Bristol-Myers Squibb, USA
  • Robust Change Management - Across the Lifecycle - Nigel Hamilton, Head of Global Quality External Affairs, Global Quality Strategy & Systems, Sanofi, United Kingdom
  • Product Tracing and Identification under the Drug Supply Chain Security Act - Connie Jung, Senior Advisor for Policy, FDA/CDER/OC, USA

And many more.

Diane Hagarty Speaking on Metrics
Diane Hagarty Speaking on the Quality Metrics Initiative

Breakout Session Photograph

Panel Discussions and Special Events

Quality Metrics Q & A – Wave 2

Mairead Goetz, Head of Compliance, Group Compliance & Audit, Group Quality Assurance, Novartis Pharmaceuticals Corporation discussed The ISPE Quality Metric Pilot Wave 1 Report and presented the next steps for Wave 2.

Breakfast with the Investigators

In one of the more popular sessions, attendees listened attentively as Milind Ganjawala, Branch Chief, Office of Manufacturing Quality, Office of Compliance and Jonathan Chapman, Investigator/BLT-DO Drug Monitor, Brooke Higgins, Senior Policy Analyst, gave their impressions of the inspection process and recommendations for ensuring a smooth inspection. After their presentation, the group spent the majority of the time fielding audience questions.

FOYA Banquet

FOYA Awards FOYA Banquet Photograph

A full room congratulated the 2015 Facility of the Year Award winners:

  • Astellas Pharma, Inc, Tube Labeling Project-Category Winner for Equipment Innovation
  • AstraZeneca China, Farmers’ Fields to Pharmaceuticals-Category Winner for Project Execution
  • IDT Biologika, Multipurpose Biologics and Vaccines Production Facility (Isolator Vaccine Filling Unit) - Category Winner for Facility Integration
  • Pharmalucence, a Sun Pharma Company, Aseptic Fill-Finish Facility - Honorable Mention

During the event, guest speaker, Mary Fitch, AICP, HON. AIA, Executive Director, Washington Chapter of the American Institute of Architecture related a personal story of how pharmaceutical architecture and good building design can be both functional and beautiful.

Mary Fitch - FOYA Guest Speaker
Mary Fitch, AICP, HON. AIA, Executive Director Washington Chapter of the American Institute of Architecture

FOYA Display
FOYA Display

Exhibit Hall

Exhibits Photograph

Exhibits Photograph

Exhibits Photograph

Just for Attendees

Thank You

Thank you to the Program Committee, speakers, attendees, exhibitors and sponsors who helped to make this year’s event such a big success!

Indicates content available to ISPE members only.

Thank You to Our Top Tier Sponsors

Handouts and Roster

Download Presentations »
(Includes Quality Metrics Wave 2 Report)

View the Attendee Roster » 

Save the date!

2016 ISPE FDA/PQRI Quality Manufacturing Conference
6 - 8 June 2016
Bethesda Marriott North
Bethesda, Maryland USA

2nd FDA/PQRI Conference On Advancing Product Quality
5 - 7 October, 2015
Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Road North
Bethesda Maryland 20852 USA
Learn more »