Hazard Analysis Following ISO 14971

Duration: 60 Minutes
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The US FDA expects that as part of a product development Design Control Program risk management will be conducted.
Hazard Analysis Following ISO 14971
Instructor: Edwin Waldbusser
Product ID: 502071
FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard.

One of the techniques described in ISO 14971 is Hazard Analysis. This is the most powerful of the risk management techniques because it considers risks in normal operation as well as fault conditions. FMEA and FTA consider only fault conditions and are more suited as reliability tools than as product safety tools.

In this webinar we will explain in detail the process of conducting a hazard analysis. The confusing terms "hazard", "hazardous situation", "harm", "causative event", "ALARP", "risk index", "residual risk" will be explained. We will go step by step through a template for hazard analysis so that the process is clear. Examples of hazards and hazardous situations will be discussed. How to deal with residual risk will be discussed. We will go step by step through a typical hazard analysis.

We will explain how to integrate Human Factors studies into the Hazard Analysis and how to integrate Hazard Analysis into the design program.

Objectives of the Presentation
  • 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
Why Should you Attend
FDA expects that as part of a product development program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Hazard Analysis is the most powerful of the risk management tools described in ISO 14971 but it is very confusing. Many new concepts are introduced. We will explain these concepts and provide examples so that the process is clear.

Who will Benefit
  • Engineering personnel
  • Software developers, IT
  • Management
  • Senior Management
  • Project Leaders
  • Regulatory Affairs
  • R&D and Engineering Staff
  • All charged with new product development, regulatory submissions, initiating / overseeing product hazard analysis and remediation
  • CAPA and P&PC personnel desiring to reduce or redirect investigation and validation costs without sacrificing product safety and/or warranty costs
  • Regulatory Personnel
  • Product Development Professionals
  • Engineers
  • QA & QC Professionals
  • Medical Device Manufacturer
  • Medical Device Designers
  • Risk Managers
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Instructor Profile:
Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices. His QS experience includes, design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/non-conforming product programs. He now consults in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis.

Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.
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