The Value of a Human Factors Program (NTZ)
At
DoubleTree by Hilton Hotel Philadelphia Airport
For more information: https://www.eventbrite.com/e/the-value-of-a-human-factors-program-ntz-tickets-42274998659?aff=RMV
DESCRIPTION
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The Value of a Human Factors Program
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 a "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:
For more information: https://www.eventbrite.com/e/the-value-of-a-human-factors-program-ntz-tickets-42274998659?aff=RMV
Why you should attend:
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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.
Areas Covered in the Session:
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HF Planning
Scope of Validation
Use scenarios
Step by step HF program development
Who will benefit:
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QA/QC Personnel
Medical Device Manufacturing
Software Developers
Engineering Managers
SPEAKER
Thomas Bento
Sr. Vice President of Regulatory & Quality Assurance, Nihon Kohden America
Thomas is a student of Quality and Regulatory Compliance and has been supporting the design, development, and compliance of Medical Device Manufacturing for over 15 years.
Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If your company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
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For more information: https://www.eventbrite.com/e/the-value-of-a-human-factors-program-ntz-tickets-42274998659?aff=RMV
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