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The Value of a Human Factors Program


An online regulatory compliance training on the topic, “The Value of a Human Factors Program”, is being organized on January 24 by Traininng.com. a leading provider of online professional training courses for the areas of regulatory compliance. Thomas Bento, Senior Vice President of Quality & Regulatory Assurance at Nihon Kohden America, which manufactures Patient Monitors, Neurological and Cardiovascular devices, will be the speaker at this session. Please enroll for this online regulatory compliance training webinar




Human Factors concerns the interrelations of humans with the elements around them. It believes that humans need to harmonize these factors for optimizing their wellbeing. In the context of organizations, Human Factors as a discipline looks at how these external environmental factors can be used within a system to help humans achieve a higher level of efficiency and wellbeing.

Today, Human Factors has evolved to such an extent that the ISO has a standard, the ISO 62366, for it. In 2016, the FDA issued its own guidance to complement this ISO standard. The ISO 62366 sets out the Human Factors requirements that medical device organizations have to implement for human usability engineering. So, medical device organizations have to be completely thorough about the workings of ISO 62366 if they have to put a compliant Human Factors or usability program in place.
This online regulatory compliance training from Traininng.com will explore the detailed aspects of this regulation. This learning is indispensable for those in the various areas of medical device Human Factors, such as QA/QC, Manufacturing, Software and Engineering. The essence of this webinar is the learning that the speaker will offer on how to implement ISO 62366 and how to meet regulatory expectations from this section.

An in-depth understanding of the ISO 62366 standard is vital since it has emerged as a "Consensus" standard. Throughout the industry, it is considered the gold standard for regulatory submissions. The speaker at this online regulatory compliance training will also offer understanding of the related standards which act as reference points for Human Factors, such as AAMI/ANSI HE75:2009. He will show the criticality of the role Human Factors Engineering (HFE) plays among device users, use environments and user interfaces, preliminary analyses, exploratory HF/usability evaluations and hazard mitigation and control.

This training course for professionals will examine the implication of HFE through Design Controls in the QSR:
 o   Design input, in which the needs of the user and patient need to be taken into account;
 o   Design validation, which ensures that devices conform to defined user needs and intended uses and which includes testing of production units under actual or simulated use conditions. Also included in Design validation are software validation and Risk Analysis inclusive of use related risks.

A Human Factors program should include interoperability and cybersecurity

Every year, the FDA publishes its priority list for the completion of its Guidance documentation, a list which sets out the agency’s priorities for inspection and enforcement. In its list for 2018, interoperability and cybersecurity ranked among the top three priority items.

For the Human Factors program of any medical device company to be robust, it must include both interoperability and cybersecurity. The safety and effectiveness of the use of the device must be validated after the implementation of the results of a Human Factors/Usability study.
This training course for professionals will help sift through the confusions many professional face in this standard. As a provider of online professional training courses, Traininng.com will, through this online regulatory compliance training, help regulatory professionals understand the ways of building a thorough and sound risk-based Human Factors program that meets regulatory expectations.
At this online regulatory compliance training, the speaker will cover the following areas:

 o   HF Planning
 o   Scope of Validation
 o   Use Scenarios
 o   Step by Step HF Program Development.

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