The Value of Human Factors
11:00 AM ET | 08:00 AM PT | 10:00 AM CT Duration 60 Minutes
Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar
"Thomas Bento is a student of Quality and Regulatory Compliance"
The ISO 62366 is noted by FDA as a “Consensus” Standard, making it a gold standard
In recent history FDA and other regulatory bodies throughout the world have been publishing their guidance and policies around Human Factor Engineering and practices. This is the result of these agencies seeing industry not addressing this critical practice in the design and development of Medical devices. This paradigm shift gives us inspection and enforcement insight into the priorities of regulators.
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 Webinar will help to sort through and demystify the confusion of the standard and help meet regulatory expectations by enumerating the tasks necessary to build a robust Risk based HF program
This webinar 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 noted by FDA as a “Consensus” Standard, making it a gold standard for regulatory submissions and product integrity. We will look at other reference points regarding HF, like AAMI/ANSI HE75:2009 and how HF Engineering include consideration of:
1. Device Users
2. Use Environments and User Interfaces
3. Preliminary Analyses
4. Exploratory HF/Usability Evaluations
5. Hazard Mitigation and Control
We will look at the implication of HFE through Design Controls in the QSR:
21 CFR Part 820.30(c) Design input –includes “needs of the user and patient”
21 CFR Part 820.30(g) Design validation – “... devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis ....”
Who will Benefit
- QA/QC Personnel
- Software Developers
- Engineering Managers
Industries who can attend
This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.