Time: February 22, 2018 at 9am to February 23, 2018 at 6pm
Location: Los Angeles, CA
Street: Los Angeles, CA
City/Town: Los Angeles, CA
Website or Map: http://www.globalcompliancepa…
Event Type: regulatory, and, compliance, seminars
Organized By: NetZealous DBA as GlobalCompliancePanel
Latest Activity: Dec 7, 2017
Course "The Value of a Human Factors Program" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
This seminar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program.
The ISO 62366 is an "Consensus" Standard, making it a gold standard for regulatory submissions. We will look at other reference points regarding HF, like AAMI/ANSI HE75:2009 and how HF Engineering include consideration of:
We will look at the implication of HFE through Design Controls in the QSR:
Why you should attend:
This year FDA published their priority list for the completion of their Guidance documentation. This FDA activity gives us inspection and enforcement insight into the priorities within the agency. Human Factors was in the #3.
Following the implementation of the results of a Human Factors/ Usability study, a validation of the safety and effectiveness of the use of the device must be conducted. This Seminar will help to sort through the confusion of the FDA Guidance and ISO standards and help meet regulatory expectations by demystifying the tasks necessary to build a robust Risk based HF program.