Hazard Analysis following ISO 14971

    /Edwin  /Waldbusserspeaker of compliance global
    Speaker: Edwin Waldbusser
    Duration: 60 Minutes
    Product Code: 700675
    Level: Intermediate
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overview

The US FDA expects that as part of a product development Design Control Program risk management will be conducted.

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 ISO 14971 risk management training 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. Also, 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.

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.

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Areas Covered

explanation of Hazard Analysis terms hazard analysis process explanation using a template examples of terms will be given hazard analysis examples will be covered step by step

Learning Objectives

Learn to conduct a meaningful hazard analysis

WHO WILL BENEFIT

  • Engineering personnel
  • Software developers
  • QA
  • Management

SPEAKER

Edwin Waldbusser retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included 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.

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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