Date:  Wednesday 21 June 2006

Time:  8.30am to 10.30am

Location:  IMC Building, Univeristy of Warwick    (Building No. 26 on Map)

Introduction

The healthcare technologies sector is a growing market, currently worth £120 billion worldwide.  Regulatory Requirements demand that medical devices placed on the market are safe and effective.  Commercial reality adds the further dimension of reliability.

It is recognised that Quality Management Systems have a central role in managing the delivering safe, effective and reliable devices to the market. 

This seminar aims to provide information on the Regulatory Requirements associated with Quality Management Systems in the medical device sector and the tools and processes an organization can use to design and implement an effective Quality Management System.

Objectives

On completion, participants will be able to:

1.  Understand the Regulatory Requirements

2.  Understand the strategic business value of an Effective Quality Management System

3.  Design and implement effective Quality Management Systems matched to Business Requirements

Contents

1.  Quality Management Systems - what they are?

2.  Why are they important?

3.  Quality Management System Effectiveness Criteria

4.  Quality Management System Implementation

     a. Understanding the business need

     b. Structure

     c. Management versus control

     d. Delegation

     e. System development tools

     f. Procedures

     g. The value of Corrective and Preventative Action Procedures

5.  Applicable standards

Delivery

This is a formal presentation.  Delegates will be given the opportunity to discuss the specific requirements of their companies during and after the presentation.

If you would like to register for the event, please click here