The second day of the 2015 ISPE/FDA/PQRI Quality Manufacturing Conference offered solution-based content from managing risk in the supply chain to modernizing facilities and enhancing quality systems to prevent drug shortages.

The final day continues with a full-day dedicated to regulatory topics lead by Thomas Cosgrove, JD Director, FDA/CDER/OC/OMQ. Throughout today’s sessions you will be able to network with international regulators and ask your most pertinent questions.

The opening session will cover topics of “Global Harmonization,” including:

  • Q7 with Larry Ouderkirk, Consumer Safety Officer, CDER/OPQ/OPPQ/DIPAP
  • ICH Q11 Starting Material Update with Timothy Watson, Ph.D., Research Fellow / CMC Advisory Office, Pfizer Inc.
  • Q12 with Mary Oates, PhD, VP, Global Quality Operations and EHS, Pfizer, Inc., USA

Gerald Heddell, Dir, Inspection Enforcement and Standards Division, MHRA of the United Kingdom will follow and discuss “Inspection Trends and Enforcement: EU Perspective.”

After lunch in the exhibit hall, the group will reconvene for the final session of the conference. Leaders of the FDA will discuss the changes at the FDA and the CDER reorganization, including:

  • Reorganization Overview – Cynthia Schnedar, JD, Director, Office of Compliance, FDA/CDER/OC
  • Office of Manufacturing Quality – Tom Cosgrove, JD, Director, Office of Manufacturing Quality, FDA/CDER/OC/OMQ
  • Office of Pharmaceutical Quality – Christine Moore, PhD, Acting Director, Office of Process and Facilities, FDA/CDER/OPQ/OPF
  • Office of Regulatory Affairs – Susan Laska, M.S., Acting Senior Advisor, Medical Products, ORA/OGROP/ORA/OO

The session will conclude with a panel discussion with the session speakers and Rick Friedman, Deputy Director, Science and Regulatory Policy, FDA/CDER/OC/OMQ; Mahesh Ramanadham, PharmD, Regulatory Operations Officer, FDA/CDER/OPQ/OPF/DIA/IABI and Francis Godwin, Division Director, Division of Drug Quality 2 (DDQ2), FDA/CDER/OC/OMQ.

We look forward to hearing about your most pressing challenges and the FDA’s and MRHA’s feedback during today’s sessions. What questions do you have for the regulators?

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