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.
Registration Fees & Deadlines
Free
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.
Speakers
Anthony Andre
Director, Interface Analysis Associates, LLC
Anthony Andre, PhD, CPE, is a world-recognized thought leader in healthcare human factors. He is director of Interface Analysis Associates LLC, a leading healthcare human factors consultancy in business since 1993. He is a recently retired professor of human factors/ergonomics at San Jose State University, the founding chair of the International Symposium on Human Factors and Ergonomics in Healthcare and the founding editor-in-chief of the journal “Human Factors in Healthcare.” Andre and his staff have been at the forefront of the combination drug product and medical device Human Factors movement, having managed and executed hundreds of HF validation programs for pharma, biotech, and medical device sponsors all over the world. Andre has provided human factors training to the FDA reviewers, and for 10 years moderated an annual FDA-Industry human factors workshop.
Carson Whitaker
Associate Director, Human Factors, Interface Analysis Associates, LLC
Carson earned his Master of Science degree in Human Factors and Ergonomics from San Jose State University. He previously completed a Bachelor of Science in Psychology with a Certificate in Human Factors from the University of Utah. While at the University of Utah, Carson managed a team in the Applied Basic Cognition Lab, gaining hands-on experience in research and leadership. He is a strong advocate for user-centered design, emphasizing correct design principles, creative problem-solving, focused research, and data analysis. Carson joined IAA in 2013. Outside of work, he enjoys building projects with his hands and spending quality time with his family.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
support@raps.org.