Management Responsibility


Plenary Session 3
Moderator:
Neil Wilkinson, NSF-DBA LLC

ICH Q10 deliberately brings to the forefront the critical area of Management Responsibility within a Pharmaceutical Quality System (PQS). Deming recognised this 50 years ago, and it subsequently became a key part of the ISO 9000 series of Quality Management standards. ICH Q10 aims to reinforce the importance of management in establishing and maintaining a company wide quality culture along with an effective PQS that assures a state of control and drives improvement.
In these sessions we will hear how these concepts are used in practice within companies and throughout their supply chains for outsourced activities and purchased materials. We will also hear from the regulators what the current expectations are as to how management should oversee the PQS.

Monday 14 November 2011
13:30 14:00 What QS means to Regulators and how Management should oversee the System
Ian Thrussell, Medicines and Healthcare Products Regulatory Agency (MHRA)
14:00 14:30 Case Study: Role of Management to Drive Industry Improvement
Anders Vinther, Genentech
14:30 15:00 Case Study: Use of Management Review to Drive Quality and Business Improvement
Kathy Diemert, Astra Zeneca
15:00 15:30 Refreshment Break

Plenary Session 4
Moderator:
Neil Wilkinson, NSF-DBA LLC

15:30 16:10 Case Study: Outsourcing and Q10 Managing the Interfaces/Contract Giver and Receiver
Mary Oates, Pfizer
16:10 16:40 Management of Supply Chain (APIs and Excipients)
Janeen Skutnik-Wilkinson, Pfizer
16:40 17:10 Panel Discussion
Ian Thrussell, MHRA; Anders Vinther, Genentech; Kathy Diemert, Astra Zeneca;  Mary Oates, Pfizer; Janeen Skutnik-Wilkinson, Pfizer; David Chesney, PAREXEL Consulting
17:10 18:30 Networking Reception


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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