Pharmaceutical Quality System


Plenary Session 1
Moderator:
David Cockburn, European Medicines Agency (EMA)

Why is a strong Quality System so fundamental to achieving and maintaining operational excellence?  What can we learn from other industries? What are the cost benefits of more effective and efficient manufacturing? In the opening session, senior leaders will discuss how the industry and consumers benefit when science-based risk management is used throughout the lifecycle to assure a robust state of control.
These sessions will address the tangible quality-business synergies reaped by "learning organisations" that proactively seek out sources of variability through daily vigilance and take advantage of contemporary technological solutions to improve product quality.

Monday 14 November 2011
08:30 08:50 Introduction to Quality System ICH Q10
Stefan Fuehring, European Commission
08:50 09:20 Industry Keynote
Richard Bowles, Merck & Co. Inc.
09:20 09:50 The Cost of Non-Compliance
Jeffrey Macher, Georgetown University
09:50 10:15 Benchmarking with Other Industries
G. K. Raju, Gland Pharma Ltd.
10:15 10:45 Refreshment Break

Plenary Session 2
Moderator:
Anders Vinther, Genentech

10:45 11:15 US Regulatory Perspectives
Richard L. Friedman, Office of Manufacturing and Product Quality FDA
11:15 11:45 European Regulatory Perspectives
David Cockburn, European Medicines Agency (EMA)
11:45 12:30 Panel Discussion
Richard Bowles, Merck & Co. Inc.; Jeffrey Macher, Georgetown University; G. K. Raju, Gland Pharma Ltd.; Richard L. Friedman, FDA; David Cockburn, EMA; Stefan Fuehring, EC
12:30 13:30 Lunch and Networking Break


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Conference Highlights

Monday 14 November 2011 Tuesday 15 November 2011 Wednesday 16 November 2011

Plenary Session 1 & 2:
Pharmaceutical Quality System

Plenary Sessions 3 & 4:
Management Responsibility

Plenary Session 5:
Lifecycle Goals

Plenary Session 6:
Quality Systems Enablers: Knowledge Management and Quality Risk Management

Plenary Session 7:
Establishing and Maintaining a State of Control

Plenary Session 8:
Pharmaceutical Quality System Elements: Process Performance and Product Quality Monitoring System

Plenary Session 9:
Pharmaceutical Quality System Elements: Continual Improvement of the Process

Plenary Session 10:
Change Management

Plenary Session 11:
Continual Improvement of the Pharmaceutical Quality System

Monday 14 November 2011
Exhibition Networking Reception