FDAs Guidance for Human Factor Engineering Seminar 2018

  • Check with publisher
  • Published date: March 6, 2018
    • Philadelphia, PA,PA, United States

Overview:
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:
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:
• Design input -includes "needs of the user and patient"
• 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 ...." [incl. use- related risks]

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.

Areas Covered in the Session:

• HF Planning
• Scope of Validation
• Use scenarios
• Step by step HF program development

Who will benefit:

• QA/QC Personnel
• Medical Device Manufacturing
• Software Developers
• Engineering Managers
Location: Philadelphia, PA Date: April 12th & 13th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: DoubleTree by Hilton Philadelphia Airport 4509 Island Avenue, Philadelphia, PA 19153


Price:

Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until February 28, Early Bird Price: $1,295.00 From March 01 to April 10, Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*
Contact us today!

NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
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Website: http://www.globalcompliancepanel.com

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