Quality System Enablers: Knowledge Management and Quality Risk Management
Plenary Session 6
Moderator:Barbara Mary Allen, Eli Lilly & Co.
The lifecycle of a product can extend over many decades and so it is important that product and process knowledge is acquired, analysed, stored and disseminated in a systematic manner. Having knowledge enables confident quality risk management to assure quality. Use of structured, formal risk management methodology facilitates consistent decision-making related to products and process controls.
Speakers at this session will share how these key topics relate to their quality management system and achievement of quality objectives.
| Tuesday 15 November 2011 | ||
| 10:30 | 11:00 | Case Study: Knowledge Management - An Iterative Process Marty Lipa, Merck & Co. Inc. |
| 11:00 | 11:30 | Case Study: Quality Risk Management - Theory and Practice Steve Liebowitz, Bristol-Myers Squibb |
| 11:30 | 12:00 | Regulatory Perspective on QRM and Knowledge Management Ian Thrussell, Medicines and Healthcare Products Regulatory Agency (MHRA) |
| 12:00 | 12:30 | Panel Discussion Marty Lipa, Merck & Co. Inc.; Steve Liebowitz, BMS; Ian Thrussell, MHRA |
| 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 |
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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 | ||