Lifecycle Goals

Plenary Session 5
Zena Kaufman, Abbott Laboratories

While the PQS is applicable from development through product discontinuation, certain elements of the PQS become more or less relevant over the lifecycle. The principles of Quality by Design can be embraced during the development to assure a product, including the processes used to manufacture and test the product can be successfully commercialised. 

This session will look at approaches for applying the elements and the tools of the PQS into development of drug substance and drug product with the goal of smooth technology transfer into commercial launch. Moreover, this session will look at lessons learned through commercialisation and post market surveillance to effect continuous improvement of the product.

Tuesday 15 November 2011
08:00 08:25 Designing and Developing Products to Meet Patient Needs under PQS
Keith Pugh, Medicines and Healthcare Products Regulatory Agency (MHRA)
08:25 08:50 Q10 Approach to Design
Georges France, Pfizer
08:50 09:15 Technology Transfer
George Millili, Merck & Co. Inc.
09:15 09:40 Case Study: Commercial Manufacturing
Kevin O'Donnell, Irish Medicines Board (IMB)
09:40 10:00 Panel Discussion
Georges France, Pfizer; George Millili, Merck & Co. Inc.; Kevin O'Donnell, IMB; Keith Pugh, (MHRA)
10:00 10:30 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