Quality System Enablers: Knowledge Management and Quality Risk Management
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)
Marty Lipa, Merck & Co. Inc.; Steve Liebowitz, BMS; Ian Thrussell, MHRA
|12:30||13:30||Lunch and Networking Break|
|Monday 14 November 2011||Tuesday 15 November 2011||Wednesday 16 November 2011|
Plenary Session 1 & 2:
Plenary Sessions 3 & 4:
Plenary Session 5:
Plenary Session 6:
Plenary Session 7:
Plenary Session 9:
Plenary Session 10:
Plenary Session 11:
|Monday 14 November 2011|
|Exhibition Networking Reception|