Conference Programme Overview

Pharmaceutical Quality Systems (ICH Q10)

Practical Solutions to Meet International Regulatory Expectations 
for Modern Quality Management Systems
Co-sponsored by FDA and Supported by EMA

14-16 November 2011 / Sheraton Hotel / Brussels, Belgium

Check latest Agenda Updates!

EARLY BIRD ON OR BEFORE
7 OCTOBER 2011
REGULAR / ONSITE AFTER
7 OCTOBER 2011
Member New Member Nonmember Member New Member Nonmember
€1.375 €1.585 €1.665 €1.675 €1.885 €1.980
           
REGULATORY / GOVERNMENT AGENCIES
€750
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


Download the Registration Form for this Conference here! ( 145 KB)

Overview
Do you want to enhance quality and reduce costs? Are you capitalising on the benefits to quality and compliance that accrue from adopting a robust quality system? ISPE, PDA, FDA and EMA have created a unique conference dedicated to successful implementation of ICH Q10. Adoption of the Q10 model for a pharmaceutical quality system should facilitate innovation, continual improvement and strengthen the link between pharmaceutical development and manufacturing activities. Join leading regulators and industry experts to learn how to implement a robust pharmaceutical quality system according to ICH Q10 that will enable you to reap the benefits of establishing and maintaining a state of control, continual improvement, enhancing regulatory compliance and meeting quality objectives.

The ICH Q10 quality system model is applicable throughout the lifecycle of a product, and complements current regional GMP requirements. At this conference you can learn what this means in practice, both from a regulatory and industry perspective. Case studies will describe successful implementations and the interface of Q10 with other key ICH guidelines that address Quality by Design and Quality Risk Management.

This is an essential conference for all involved in product development, quality, manufacturing and regulatory affairs. Understanding of ICH Q10 is vital at all levels of the organisation from senior management, who have the responsibility for establishing and maintaining a company-wide commitment to quality and for the performance of the quality system, through scientists and engineers responsible for products (both development and manufacturing), processes, equipment and facilities.

Learning Objectives

  • Learn the principles of ICH Q10
  • Learn the practicalities of how to implement Q10 based on real-life case studies
  • Understand the benefits of establishing and maintaining a state of control to enhance regulatory compliance

Who Should Attend

You should attend this conference if you are a decision-maker at mid-level or senior level, or a professional working at site or corporate level in the following areas:

  • Quality Assurance
  • Manufacturing, Operations and Engineering
  • Six-sigma and Quality by Design
  • Quality Risk Management
  • Supply Chain
  • Pharmaceutical Development and CMC
  • Regulatory Affairs

Contacts

For further information about the European Conference, please contact:
Paul-Kilian Jordan
Vice President, European Operation
ISPE
Tel: +32 2 743 44 38
Email: paul-kilian.jordan@associationhq.com
www.ISPE.org