Hazard Analysis following ISO 14971

Product Id : FDA08
Instructor : Edwin Waldbusser
Mar 15, 2017 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes


Food and Drug Administration (FDA) expects that risk management will be conducted as part of a product development design control program, and it recommends that ISO 14971 be used as a guide for the same. However, ISO 14971 is very confusing for many professionals. If you are among them, this webinar will help you. Learn how.

The US FDA accepts ISO 14971 as an acceptable standard, and recommends that it be used as a guide. However, ISO 14971 and the process of conducting a hazard analysis itself, is confusing to many professionals. During this webinar, our expert speaker will walk you through the subject, explaining the key points in simple detail, so you understand the subject and are able to perform your job better.

Of the techniques described in ISO 14971, the most powerful is Hazard Analysis. This is the technique which will be discussed extensively during the webinar, because as opposed to the rest, it also considers risks in normal operation, as well as fault conditions. Other techniques such as FMEA and FTA only consider fault conditions – which makes them better as reliability tools, as opposed to tools for product safety.

You will learn how to conduct a Hazard Analysis, step by step. For this, our speaker will take you through a template, and later through a typical Hazard Analysis. Apart from that, confusing terms such as ‘hazard’, ‘hazardous situation’, ‘residual risk’, ‘causative index’, ‘risk index’, ‘harm’ and ‘ALARP’ will be explained, and a few examples of hazards and hazardous situations will be discussed. Another subject under discussion will be residual risk, and how it is to be dealt with.

However, that is not all. You will also learn how to integrate Human Factors studies into the analysis, and how to integrate Hazard Analysis into the design program. Sign up for this webinar to learn all this and more, so you can do your job efficiently.

Training Highlights:

  • Understand the new concepts of Hazard Analysis, to avoid confusion
  • Why is Hazard Analysis the best technique?
  • Learn what terms such as ‘harm’, ‘causative event’, ‘residual risk’ and ‘ALARP’ mean
  • Discuss examples of hazards and hazardous situations
  • Learn how to deal with residual risk
  • Learn how Human Factors studies are integrated into the Hazard Analysis
  • Learn how Hazard Analysis is integrated into the design program

Who will benefit:

The following people will benefit from, and should therefore attend this webinar:

  • Regulatory Personnel
  • Product Development Professionals
  • Engineers
  • QA & QC Professionals
  • Medical Device Manufacturer
  • Medical Device Designers 
  • Risk Managers 
  • Software Developers
Speaker Profile:

Edwin Waldbusser is a Regulatory Consultant at Medical Device Advisors. He is holder of BSc. Mechanical Engineering and Master in Business Administration.

After more than 20 year of work and retirement from management of medical devices development (5 patents), Mr. Waldbusser is now a highly experienced consultant. He has been a consultant in the fields of risk analysis, software validation and design control for 8 years now.

Mr. Waldbusser is a Lloyds of London ISO 9000 Lead Auditor. He is also a board member of Thomson Reuter Expert Witness network.

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