Pharmaceutical Quality System Elements: Process Performance and Product Quality Monitoring (PPPQM) System

Plenary Session 8
Joe Famulare, Genentech

This session will focus on the ability of a company to drive continual improvement of the lifecycle of a product through a robust PPPQM system element. Using sound approaches in development form the basis for a quality product, however implementation of this PQS element captures the rich data and knowledge that is obtained throughout the lifecycle phases of tech transfer, commercial manufacturing, through product discontinuation.
Topics will include traditional indicators such as batch data, deviations, complaints, CAPAs, and leading indicators such as the product steward model, evaluating quality across a global network and use of statistical tools. The opportunity exists to provide process capability measurements to have a true state of control in pharmaceutical manufacturing and support modern day approaches to lifecycle validation.

Tuesday 15 November 2011
15:30 16:00 Product Quality Indicators
Nigel Hamilton, Sanofi
16:00 16:30 Product Quality Management
Deborah Baly, Genentech
16:30 17:00 Case Study: Use of Statistical Process Control Approaches to detect Process Drift - Using Process Capability Measurement
Helmut Rockstroh, Roche
17:00 17:30 Panel Discussion:
Lina Ertlé, AFSSAPS; Gretchen Allison, Pfizer; Nigel Hamilton, Sanofi; John McShane, Genentech; Deborah Baly, Genentech; Helmut Rockstroh, Roche
17:30   Close of Session

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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