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Site language : English - Français
Ref : 26167
Event :The Value of a Human Factors Program

Date :Friday January 12th, 2018

Location :Online (Internet, Videoconferencing, ...)

Type :Education - International audience

Accreditation :--


 

Further information

Overview:  
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.
 
Why should you Attend:
This year FDA published their priority list for the completion of their Guidance documentation. This annual activity gives us inspection and enforcement insight into the priorities within the agency. Interoperability and Cybersecurity were in the top 3. The implementation of a robust HF program will include both of these disciplines. 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 the confusion of the standard and help meet regulatory expectations by enumerating 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
Manufacturing
Software Developers
Engineering Managers
 
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

Further information

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Announcer

Compliance4All
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All [...]

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Details

The Value of a Human Factors Program Medicine - Management - Pharmacy
human factors program, development, software developers, compliance programs, design validation, hazard mitigation, medical device manufacturing
Professionals, Manufacturing Software Developers Engineering Managers
100 1 --
English

Other

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