Quality System Enablers: Knowledge Management and Quality Risk Management
Plenary Session 7
Moderator: 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 |
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Plenary Session 1 & 2: Plenary Sessions 3 & 4: |
Plenary Session 5: Plenary Session 6: Plenary Session 7: Plenary Session 8: |
Plenary Session 9: Plenary Session 10: Plenary Session 11: |
| Monday 14 November 2011 | ||
| Exhibition Networking Reception | ||