In its third year, the ISPE/FDA/PQRI Quality Manufacturing Conference will bring together leaders of the pharmaceutical industry and international regulators for three days of education sessions and panels packed with need-to-know Regulatory Insights, Manufacturing Innovations and Quality Systems Advances.

During the conference, you can expect to:

  1. Discuss Q7, Q11 and Q12 inspection trends and FDA views on Track and Trace and Global Harmonization
  2. Discover cutting-edge technologies from innovative companies that could improve your processes and bottom-line
  3. Receive an update on the ISPE Quality Metrics Pilot Report and the outcomes of the ISPE Quality Metrics Summit
  4. Take away solution-based approaches for facility operations, drug shortages prevention, continuous manufacturing and foundations for quality Lifecycle knowledge management
  5. Attend one full day dedicated to regulatory topics. FDA will discuss the CDER reorganization and their new roles and priorities.

Additionally, during the keynote sessions, you will hear from Janet Woodcock, MD, Director, CDER, FDA, Juan Andres, Head of Technical Operations, Novartis AG, and Andrew Skibo, Head of Global Biologics Operations and Global Engineering, MedImmune/AstraZeneca and their insight on FDA Quality Initiatives, Promoting Quality with Innovative Manufacturing and Supply Chain Risk Management, respectively.

There will also be countless onsite networking opportunities with regulatory leaders throughout the conference including Thomas Cosgrove, JD, Director, FDA/CDER/OC/OMQ and Gerald Heddell, Director, Inspection Enforcement and Standards Division, MHRA, United Kingdom during special sessions, such as the Breakfast with the Investigators, and receptions in the exhibit hall.

The exhibit hall will be open on Monday and Tuesday giving you plenty of time to meet with suppliers like Bausch + Stroebel Machine Company, Inc. and Genesis Packaging Technologies. The complete list of exhibitors is located in the Exhibitor Directory on the conference website.

With the conference in one week, start planning your trip early by reviewing the education program, finding exhibitors and planning your personalized conference agenda. We look forward to seeing you in Washington, DC!

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