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Monday, 4 June
07.30 – 09.00 Continental Breakfast
09.00 – 09.45 Plenary Session 1: Vision for Quality in the 21st Century
Janet Woodcock, Director CDER, FDA, USA
09.45 – 10.30 Plenary Session 2: Lean Manufacturing Without Compromising Quality
Andy Skibo, Executive Vice President, Operations, MedImmune, USA
10.30 – 11.00 Networking Break
11.00 – 12.15 1A: Benefits of PAI Readiness and Data Integrity for Speedy Approvals
1B: Why It Pays to Continually Reinvest in Your Facilities & Systems
12.15 – 13.15 Lunch
13.15 – 14.00 Plenary Session 3: Global Quality
Deborah Autor, Deputy Commissioner for Global Regulatory Operations and Policy, FDA, USA
14.00 – 15.30 2A: Regulatory Success in a Cloud Environment
2B: Sustaining Compliance Consistency throughout Your Supplier Networks
15.30 – 16.00 Networking Break
16.00 – 17.00 Forum 1: Industry-Led Hot Topic Discussion Forum
17.00 – 18.30 Networking Reception in Exhibit Hall
Tuesday, 5 June
07.00 – 08.00 Continental Breakfast
08.00 – 08.45 Plenary Session 4: Future Vision for the Office of Compliance
Ilisa Bernstein, Acting Director, Office of Compliance, CDER, FDA, USA
08.45 – 09.30 Plenary Session 5: Culture of Quality
Mary Oates, Vice President of Global Quality Operations, Pfizer, USA
09.30 – 10.15 Plenary Session 6: International Regulatory Perspective
Gerald Heddell, Director of Inspection, Enforcement and Standards, MHRA, UK
10.15 – 11.00 Networking Break in Exhibit Hall
11.00 – 12.30 3A: Watching Your Process - Assuring Quality and Process Performance
3B: Quality Risk Management: Using Risk Assessments in Manufacturing
12.30 – 13.30 Lunch
14.30 – 15.15 Forum 2: Meet The Press
15.15 – 17.00 Networking Break in Exhibit Hall
15.15 – 17.00 4A: Flexible Manufacturing
4B: CAPA : Case Studies

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