Continual Improvement of the Pharmaceutical Quality System

Plenary Session 11
David Cockburn, European Medicines Agency (EMA)

Throughout the conference, participants will have been shown how the key elements that make up a successful pharmaceutical quality system can be implemented in a practical way including continual improvement of products and processes. Once the pharmaceutical quality system is established it will need to be maintained and developed.  
The final session focuses on continual improvement of the pharmaceutical quality system itself. The session will show how the system contributes to its own improvement as well as the internal and external factors that must be taken into account to keep the system fit for purpose.

Wednesday 16 November 2011
13:00 13:30 The Importance of Continually Improving Your PQS
Jacques Morénas, French Agency for the Safety of Health Products (AFSSAPS)
13:30 14:00 Case Study: How do You Know if Your PQS is a Healthy One?
Zena Kaufman, Abbott Laboratories
14:00 14:30 Complacency is not an Option
Vicki Soteres, Eli Lilly
14:30 15:00 Panel Discussion
Jacques Morénas, AFSSAPS; Zena Kaufman, Abbott Laboratories; Vicki Soteres, Eli Lilly; Mike James, GlaxoSmithKline; Rob Hughes, Astra-Zeneca
15:00 15:15 Close of Session
David Cockburn, EMA

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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