Active Quality Systems: another perspective on quality assurance

10 October 2007, the Chartered Quality Institute, 12 Grosvenor Crescent, London SW1X 7EE

Format

A one day interactive workshop for the medical device sector

Who should attend

Those with any level of responsibility for quality assurance within a small or medium sized business

Workshop objectives

To examine the reasons why quality systems so often fail to live up to expectations
To explore and gain an understanding of the standpoints of all parties
To develop an outline strategy for change

Workshop style

An informal environment, to promote active participation, questions, debate and creativity. Please note: because this is a workshop, places are limited to 20 people.

Expected outcomes

An increased ability to align quality systems to the business strategy
A more "hands on" approach across the business
An improved understanding of how to design processes that people want to use

Programme

09:30	Arrival and Coffee
09:45	Introductions
10:00	Morning Session Who are we? Perception versus reality Are quality assurance systems being taken seriously? What are our responsibilities and the responsibility of the system? What are the characteristics of an effective quality management system?
12:30	Lunch
13:15	Afternoon Session How can we achieve our goals? Educating others Communication and "buy in" Review of our performance Summary of the drivers Individual action plans
14:45	Evaluation
15:00	Close

Booking

This event costs £60 (CQI members), £100 (non-members) excluding VAT. Book online now. Due to the nature of the event places are limited to 20 so early booking is essential.

Biography

James Love
BSc ACGI MBA MIMechE CEng

James Love is a degree qualified professional mechanical engineer with experience in a number of sectors, including, automotive, industrial equipment, chemical, international management development, domestic appliances and medical devices. As Vice President - Engineering, for a high volume medical device manufacturer, with offices in the UK and the USA and with a manufacturing facility in Hungary, he was responsible for the engineering, regulatory and quality functions. He managed the restructuring of the quality management system, into an effective management tool, prepared a number of FDA approval applications, as well as collating technical files for Notified Body assessment in Europe.

James is a member of the Regulatory Affairs Professionals Society, and spoke at their 2004 European Conference on designing quality management systems to suit a multi-standard environment. He is also on the steering committee of the Medical Technologies Special Interest Group, co-sponsored by the Chartered Quality Institute and the American Society of Quality - Biomedical Division

James has been involved with product development and quality for most of his professional life and is named as the inventor in a number of patents and patent applications. He is a Director of Innoventions Medical Ltd providing advice on product development management, quality management systems and regulatory affairs. He is also the Technology Director of HealthTech Organisation Limited assisting small and medium sized enterprises in the health care sector, as well as being a Director of Medi Immune, a start up company developing innovative immune system sensitising devices.

James works closely with and addresses medical device issues for the United Kingdom CE Marking Association.

Innoventions Medical Limited
121 Meeting House Lane
Balsall Common
Coventry
CV7 7GD

t +44 (0) 1676 532386 f +44 (0) 1676 532181 m +44 (0) 7817 258473 e james@innoventionsmedical.co.uk

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