Webinar Duration: 60 minutes
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: Edwin Waldbusser
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 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.
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.
Areas Covered in the Session:
– 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
Who Will Benefit:
– Engineering Manager
– Regulatory Personnel
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.