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Highlights - ISPE/FDA/PQRI Quality Manufacturing Conference
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2016 ISPE/FDA/PQRI Quality Manufacturing Conference

We’re just days away from the kick-off of the most important regulatory event of the year –  the 2016 ISPE/FDA/PQRI Quality Manufacturing Conference. The program committee worked hard to develop a comprehensive program to help you navigate the increasingly complex nature of regulatory compliance and quality expectations. Still trying to finalize your itinerary for the conference? Here are some highlights to help you prepare:

Education Tracks

There’s something for everyone to learn with four education tracks that cover a wide array of key issues and emerging trends on quality manufacturing. Discover valuable solutions that can be applied immediately from our in-depth education sessions.

  • Manufacturing and Operational Excellence – Investigate practices that improve manufacturing and prevent drug shortages.
  • Transformation of Review and Inspection in Quality Oversight – Gain insight into FDA's new focus on "One Quality Voice" through the integration of multiple review inspection units.
  • Frontiers in Manufacturing Science and Quality – Explore cutting edge developments and revolutionary approaches in drug product and delivery.
  • Progress in Quality Metrics – Understand the impact of developing regulations on company program implementation and investment.

Featured Session

Quality Metrics – Wave 2 and Implementing Your Metrics The ISPE Quality Metrics team and the FDA Quality Metrics leaders will share their insights and help you prepare to implement your own program. The session will:

  • Unveil findings from the Quality Metrics Pilot – Wave 2
  • Provide clear direction from the FDA on the expectations for implementation
  • Offer open discussion with Pilot organizers and the FDA to address all your concerns
  • Explore how organizational culture may impact your implementation program

ISPE Quality Metrics Wave 2 Report, Quality Metrics Webinar, and Drug Shortages Webinar

Attendees will be informed when the Quality Metrics Wave 2 Report, Quality Metrics Webinar, and Drug Shortages Webinar are available for download.

Keynote Speakers

Hear from these dynamic keynote speakers:

Lynne Krummen - Keynote Speaker 2016 ISPE Quality Manufacturing Conference Dara Corrigan - Keynote Speaker for 2016 ISPE Quality Manufacturing Conference Micheal Kopcha - Keynote Speaker 2016 ISPE Quality Manufacturing Conference Steven Solomon - Keynote Speaker 2016 Quality Manufacturing Conference
Lynne Krummen, PhD Vice President, Global Head for Biologics, Technical and Regulatory and the Global Lead for Quality by Design, Genentech, Inc., A Member of the Roche Group
Dara Corrigan, JD Associate Commissioner for Global Regulatory Policy, FDA/OC/OGROP, USA
Michael Kopcha, PhD, RPh Director, Office of Pharmaceutical Quality Offices and Leadership, FDA/CDER/OPQ, USA
Steven Solomon, PhD DVM, Deputy Associate Commissioner for Regulatory Affairs, FDA/ORA/OACRA, USA

With the interactive sessions and unique opportunities to network with more than 25 FDA regulators, the 2016 ISPE/FDA/PQRI Quality Manufacturing Conference is the go-to event to enhance your knowledge and connections in all things quality manufacturing. Still need more information to craft your ideal event itinerary? Check out the conference agenda for more details. Follow the official conference hashtag, #ISPEQM, to stay up-to-date on what others are sharing at the conference, updates, and notifications on can’t miss events.