FDAs Guidance for Human Factor Engineering Seminar 2018

Start Date : April 12, 2018
End Date : April 13, 2018
Time : 9:00 am to6:00 pm

Phone : (800) 447-9407
Email : support@globalcompliancepanel.com

Location :
DoubleTree by Hilton Philadelphia Airport 4509 Island Avenue, Philadelphia, PA 19153

Website

Description








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Course "The Value of a Human Factors Program" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


 


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:



 


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:


 



 


Who will benefit:


 



 


 


 


Agenda:


 


Day 1 Schedule


 


This session will demystify the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program and the implementation of ISO 62366 Standard


Lecture 1:


Definitions, requirements and approaches for Human Factor Engineering using ISO 62366



Lecture 2:


Introduction to FDAs Guidance for Human Factor Engineering



Lecture 3:


Strategies to detect and avoid HFE issues



 


Day 2 Schedule


 


This session will introduce you to ANSI/AAMI HE75:2009(R)2013 Human Factors Engineering-Design Specifications as they relate to medical devices and medical related software. You will walk away with a better understanding of the impact these requirements have on your product lifecycle and related product release schedule.


Lecture 4:


Definitions, requirements and approaches for Human Factor Engineering using HE-75



Lecture 5:


HFE Usability Testing



Lecture 6:


HFE Labeling



Lecture 7:


HFE Design



 


 


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. He started his career training in Software engineering and shortly moved into Commercial Software Quality. After many years of working for companies like Mitek Systems and Hewlett Packard, the decision was made to work in the regulated space of Medical Device Manufacturing, working at Edwards, Pulmonetic Systems and as a regulatory consultant for small, medium and large Medical device manufactures.


He is currently the Sr. Vice President of Quality & Regulatory Assurance at Nihon kohden America, manufacturers of Patient Monitors, Neurological and Cardiovascular devices.


Through his experience he has found that most Medical Device Manufactures feel that more is better to meeting regulatory expectations. He finds that this is the exact opposite and that manufacturers are better off by cultivating a simplified defensible approach to regulatory compliance.


 


 


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%)*


Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar


At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.


As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory-related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.


For More Information- https://www.globalcompliancepanel.com/control/sponsorship 


 


Contact us today!


 


NetZealous LLC DBA GlobalCompliancePanel


john.robinson@globalcompliancepanel.com  


support@globalcompliancepanel.com 


Toll free: +1-800-447-9407


Phone: +1-510-584-9661


 Website: http://www.globalcompliancepanel.com


 


Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901504SEMINAR?SEO


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NetZealous LLC DBA GlobalCompliancePanel ,
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

Tel: 800-447-9407
Email: support@globalcompliancepanel.com
Website: https://www.globalcompliancepanel.com/





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