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.
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