Quality System Enablers: Knowledge Management and Quality Risk Management

Plenary Session 6
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

Plenary Session 1 & 2:
Pharmaceutical Quality Management 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