Sponsored Webcast: Demystifying the Use-Related Risk Analysis (URRA) in Human Factors Validation Programs (On Demand)
This webcast will introduce the audience to the Use-Related Risk Analysis (URRA), a specific risk management document/tool used exclusively in the human factors validation programs for FDA approval/clearance. The URRA is a unique risk management approach that differs in construction and mind set from other risk management documents and activities. As such, it is often a roadblock for sponsors of combination products and medical devices and can delay or prevent approval/clearance if not approached correctly.
During the webcast, we will share with the audience a proven approach to both the construction of the URRA and its use in the HF validation program. Attendees will gain valuable insight on how to approach the URRA as well as human factors risk management for future projects and realize how different it is in basis, construction and use from other risk management activities associated with the same product.
Learning Objectives
- Understand how the URRA is different in construction and use than any other risk management document.
- Understand how to construct a URRA per FDA guidance.
- Learn a different way to think about harm and risk.
- Learn how to approach critical task designation, severity, and harm.
- Learn why playing the “risk game” in human factors will hurt you more than it will help you.
Who Should Attend?
Regulatory professionals, device engineers, product managers, quality managers and human factors professionals who want to better understand how to construct and use a URRA that the FDA will find acceptable.
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Speakers
Anthony Andre
