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Changes in ISO 14971:2007 and a review of best practice since 2000

29 April 2008, Royal Pharmaceutical Society, 1 Lambeth High Street, London SE1 7JN

Meeting design

Initially our keynote speaker will set risk management into the context of medical device quality management systems and product design / development and continue with an insight into the 2007 revisions of ISO 14971 from an expert consultant intimately involved with the development of the much extended standard. The morning concludes with a review of the tools and techniques of Risk Management from a leading international practitioner.

In the afternoon we commence with medical device regulators' views of risk management implementation on both sides from both sides of the Atlantic, before addressing the critical issues of risk acceptance policy and technology appraisal. The day concludes with a panel discussion where our speakers will take questions on anything about risk management from the floor. Please do not be in hurry to leave at the meeting, as panel discussions have been known to stimulate lively discussions in the adjacent hotel bar!

Who should attend

The day is designed to be of advantage to those new to risk management, those wishing to update their knowledge of standards and best practice, as well as established practitioners who can benefit from other's experience and Directors who will take the ultimate responsibility.

• Engineers and Designers
• QA/RA Professionals
• Senior Managers and Directors

Programme

The speaker list and programme may be revised nearer to the event.

Fees and bookings

The early-bird registration fee is £175 plus VAT before 1 April
The standard registration fee is £195 plus VAT after 1 April
CQI Members discounted registration fee is £155 plus VAT

Book online or telephone +44 (0)20 7245 6722

Speaker biographies

Edward R. (Ed) Kimmelman

Regulatory Affairs / Quality Systems Consultant
Ed Kimmelman provides consultant services in the areas of regulatory submissions, regulatory compliance, and quality management systems. During a thirty-five year career in industry he has served in engineering, product management, and senior management positions for the DuPont Co. and the Roche Diagnostics Corp. Ed is a past President of the NCCLS and has served as Chairman of the HIMA Standards Section and Science and Technology Section. He is currently the convenor of the ISO/TC210, Working Group 1 on quality systems.
Ed received a B.S. degree in mechanical engineering from Cornell University and a J.D. degree from the Seton Hall University School of Law

Oliver P Christ, Dipl.-Ing.

CEO Healthcare of PROSYSTEM AG an international consulting company for the Healthcare Industry providing multiple services concerning Risk-Management, Quality Assurance Software Validation and Usability Engineering.
The company PROSYSTEM AG was founded by Mr. Oliver P. Christ together with his business partner Dr. Juergen Stettin in 1999 and is located in Hamburg, Germany having an US-based office in San Diego, California. Mr. Oliver P. Christ has been active in International Standardisation for more than 17 years. In Germany he is Chairman of four National Committees two on "Human Factors / Usability for Medical Devices", one on "Risk-Management for Medical Electrical Equipment" as well as for "Software for Medical Devices and Networked-Medical Systems". He represents Germany within International Standard Committees on Programmable Electrical Medical Systems (since 1992), Human Factors (since 1996), Risk Management (since 1996) Software Life Cycle Processes (since 2002), and Risk-Management for IT-networks incorporating Medical Devices (2006).

Mark Boult MA MBA

UK Leader for DNV's Healthcare Market Sector
Mark is currently responsible for the standards, assessment and education services provided by DNV for the NHSLA to trusts throughout England. Over the last four years' Mark was the Risk Management advisor to, and a management team member for the National Patient Safety Agency (20002 to 2006).
Mark specialises in risk and safety management and analysis, and has considerable experience in leading and undertaking risk management reviews and risk analyses for Healthcare clients. Projects he has managed include drafting risk management policy and procedures, supporting the integration of risk management systems between NPSA and other agencies, review of the National Programme for Information Technology with regard to patient safety for the Department of Health and jointly drafting the Patient Safety Risk Assessment guidelines for the "Hospital at Night" changes in the NHS.

William (Bill) Midgette

Senior Electronics Engineer, Medical Electronics Branch
Division of Electronics and Computer Science, Office of Science and Technology Center for Devices and Radiological Health, U.S. Food and Drug Administration
In his current position, Mr.Midgette's primary responsibility is risk management, and reliability. He is the primary FDA liaison to (1) ISO TC 210 Quality Systems and Corresponding General Aspects for Medical Devices JWG1 Application of Risk management to Medical Devices, (2) IEC TC 62A Common Aspects of Electrical Equipment Used in Medical Practice WG 15 Risk Management, and (3) IEC TC 56 Dependability WG 3 Equipment Reliability Verification. He has both a BSEE and MSEE. He has completed post-graduate studies at the University of Maryland in reliability and technical risk management. He is a Senior Member of the Institute of Electrical and Electronics Engineers (IEEE). He performs reviews of risk management and reliability information in premarket submissions and served as a member of the FDA review team for mechanical circulatory-support devices.

Sunita Ahir

Project Manager/Product Technical Specialist - Healthcare - BSI Product Services
TBA

Liam Keary

Worldwide Quality Risk Management Director - DePuy a Johnson & Johnson Orthopaedics Franchise.
Prior to holding this position he was head of quality for the Franchises largest manufacturing facility based in Cork Ireland. Before joining DePuy he had held both site and international Quality and Operational roles with a number of electronics design and manufacturing organisations covering Telecoms, IT, Automotive, Medical and Defense industry sectors. In all cases Liam has been responsible for defining, developing and deploying risk management policy at both site and global organisational levels. He received his Bachelor degree in Electronics Production in the University of Limerick.

Jo Richardson

NICE Health Technology Analyst
Joanna Richardson joined the National Institute for Health and Clinical Excellence in May 2003 as a health technology analyst for the appraisal team. She has been the technical lead for a number of pharmaceutical, device and therapy appraisals. Currently a technical advisor in the Centre for Health Technology Evaluation she advises technical leads working on a number of appraisals. Prior to joining NICE, Joanna worked for the Focus project (which promotes effective practice in child and adolescent mental health) based at the Royal College of Psychiatrists' Research Unit and was a practice associate for the National Children's Bureau. She has an MSc in Health Psychology and a Post-graduate Certificate in Health Economics.