Pharmaceutical Quality System Elements - Continual Improvement of the Process (CAPA)

Plenary Session 9
David Chesney, PAREXEL Consulting

An effective CAPA system has been an expectation for many years for companies operating to ISO 9000 Quality Management standards, including Medical Devices operating to ISO 13485. The Pharmaceutical Industry has over the last decade put significant effort and resources, in a reactive mode, to managing and investigating deviations, resulting in corrective actions. However, there has been less focus on proactively undertaking preventative actions within the CAPA system.

ICH Q10 requires an effective CAPA system that identifies areas for improvement as product and process understanding expands, implements improvements, and monitors effectiveness. It is essential that the CAPA system does not work in isolation and that there are strong linkages with other aspects of the PQS, including Management Review. In this session speakers will present real examples of how a CAPA system can be linked within the PQS to contribute to continual improvement and a reduction in repeat issues.

Wednesday 16 November 2011
08:00 08:30 CAPA
Martin VanTrieste, Amgen
08:30 09:00 Process Improvement
Juan Andres, Novartis International AG.
09:00 09:30 Management support for Continual Improvement
Jeff George, Sandoz
09:30 10:00 Panel Discussion:
Martin Van Trieste, Amgen; Juan Andres, Novartis International AG; Jeff George, Sandoz
10:00 10:30 Refreshment 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