Tuesday, 5 November 2013, 8:00-11:30
Associate Director, CDER/OC/OMPQ, FDA
VP Compliance and External Relations, Genentech
Rapporteur ICH Q 10 Pharmaceutical Quality Systems
In the FDASIA provisions enacted by Congress in 2012, the legislation states the term “current good manufacturing practice” includes the implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products.
This session will explore how FDA is looking at Pharmaceutical Quality Systems and the Role of Senior Management in pharmaceutical quality and cGMP implementation since the passage of FDASIA. This session will reveal FDA’s latest thinking on the topic now as the Agency continues to implement the Drug Safety provisions of FDASIA. Understand why it is necessary to have an effective quality system in order to have one that is cGMP compliant. Learn the effects that the implementation of a Pharmaceutical Quality System have had from an industry perspective since the FDA and ICH guidelines have published, and the FDASIA GMP requirement for proper management oversight. In this important session, learn:
Richard Friedman U.S. FDA, CDER, OMPQ, Associate Director, Co-Chair FDA Quality Systems Workgroup
Bob Sausville U.S. FDA, CBER, Director Case Management, Office of Compliance, Co-Chair FDA Quality Systems Workgroup
Joseph C. Famulare, VP, Global Compliance & External Collaboration, Genentech
Barbara Allen, Ph.D., Senior Director, Global Quality Systems, Eli Lilly
Zena G. Kaufman, SVP Quality, Hospira Inc. (invited panelist)
Monday, 4 November 2013, 14:00-17:30
Continuing the success of the Quality Metrics workshops at the ISPE/FDA CGMP Conference in June 2013, this session will present the next phase in this critical conversation between industry and regulators. The session will open with an update from Russ Wesdyk, OSP Scientific Coordinator, FDA on where the FDA stands in regard to Quality Metrics and what they perceive to be the critical factors to engaging and preparing the pharmaceutical industry. Pending the development of the OPQ that Janet Woodcock has envisioned this initiative could have an immediate and extensive impact on your daily procedures. Presentations from the ISPE Quality Metrics working groups on potential metrics for Batch Failure Rates, OOS/Lab Failure Rates, and Leading Quality Metrics and New Ideas will be on the agenda. This is your opportunity to ask questions directly of the experts navigating this very important development. The tangible outcome of the session will be a white paper to be presented to the FDA as a recommended path forward. Don’t miss this opportunity to shape your industry!
Russ Wesdyk, Science Coordinator, FDA
Cindy Salamon, VP, Global Quality Services, Bristol-Myers Squibb, USA
Lorraine McClain, Senior Director Quality Compliance, Teva Pharmaceuticals
Lorraine Thompson, Quality Systems Implementation Director, Novartis, USA
Continue the conversation with industry leaders and invited regulator on Tuesday Morning from 7:00am – 8:00am in Maryland I, Lobby Level. Limited seating available, please sign-up during the Quality Metrics Session on Monday Afternoon from 14.00 – 17.30 Washington 6, Exhibition Level.