Plenary Sessions

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FDA has joined with ISPE to deliver an integrated learning conference focused on Industry and Regulatory viewpoints. A powerhouse line up of Global regulators and industry health and trade organization leaders discuss evolving compliance issues, improving good manufacturing practices and how to navigate today's pharmaceutical industry. This is a conference you do not want to miss!

Plenary Sessions: Monday, 4 June 2012

	9.00 – 9.45 Plenary 1 *Vision for Quality in the 21st Century* Janet Woodcock, Director CDER, FDA, USA View Janet Woodcock's Biography
	9.45 – 10.30 Plenary 2 *Lean Manufacturing Without Compromising Quality* Andy Skibo, Executive Vice President, Operations, MedImmune, USA View Andy Skibo's Biography
	13.15 – 14.00 Plenary 3 *Global Quality* Deborah Autor, Deputy Commissioner for Global Regulatory Operations and Policy, FDA View Deborah Autor's Biography

Plenary Sessions: Tuesday, 5 June 2012

	8:00 – 8.45 Plenary 4 *Future Vision for the Office of Compliance* Ilisa Bernstein, Acting Director, Office of Compliance, CDER, FDA View Ilisa Bernstein's Biography
	8.45 – 9.30 Plenary 5 *Culture of Quality* Mary Oates, Vice President of Global Quality Operations, Pfizer, USA View Mary Oates' Biography
	9:30 – 10.15 Plenary 6 International Regulatory Perspective: What's New in Europe? Gerald Heddell, Director of Inspection, Enforcement and Standards, MHRA View Gerald Heddell's Biography

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