Quality System Enablers: Knowledge Management and Quality Risk Management

Plenary Session 7
Joe Famulare, Genentech

As defined by Q10 a state of control is a condition in which the set of controls consistently provides assurance of continued process performance and product quality. This session will discuss the effective monitoring and control systems that can achieve assurance of continued suitability and capability of processes.
Featured in this session will be how effective monitoring can support these goals and how they enable lifecycle approaches to validation i.e. continued process verification. This applies to conventionally manufactured products and those that feature advacnced manufacturing and control technologies utilising innovative approaches to process validation.

Tuesday 15 November 2011
13:30 14:00 State of Control Over the Lifecycle and Process Validation (New and Legacy Products)
Lina Ertlé, French Agency for the Safety of Health Products (AFSSAPS)
14:00 14:30 Case Study: Conventional and Modernised Process using Knowledge from Development and Lifecycle Monitoring to Support Continued Product Verification
Gretchen Allison, Pfizer
14:30 15:00 Case Study: Lifecycle Input to Support Continued Product Verification and State of Control of the Commercial Scale Process
John McShane, Genentech
15:00 15:30 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