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UID:2140535:Event:77620
DTSTAMP:20260521T185447Z
SUMMARY:The Value of a Human Factors Program
DESCRIPTION:Overview: This webinar will explain the implementation of 
 ISO 62366 and the regulatory expectations discussed in the 2016 FDA Gu
 idance for a compliant human factors/ usability program.\nWhy should y
 ou Attend:This year FDA published their priority list for the completi
 on of their Guidance documentation. This annual activity gives us insp
 ection and enforcement insight into the priorities within the agency. 
 Interoperability and Cybersecurity were in the top 3. The implementati
 on of a robust HF program will include both of these disciplines. Foll
 owing 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 c
 onfusion of the standard and help meet regulatory expectations by enum
 erating the tasks necessary to build a robust Risk based HF program.\n
 Areas Covered in the Session:HF PlanningScope of ValidationUse Scenari
 osStep by Step HF Program Development\nWho Will Benefit:QA/QC Personne
 lManufacturingSoftware DevelopersEngineering Managers\nSpeaker Profile
 :Thomas is a student of Quality and Regulatory Compliance and has been
  supporting the design, development and compliance of Medical Device M
 anufacturing for close to 15 years. He started his career training in 
 Software engineering and shortly moved into Commercial Software Qualit
 y. After many years of working for companies like Mitek Systems and He
 wlett 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 dev
 ice manufactures.\nEvent Fee: One Dial-in One Attendee Price: US$150.0
 0\nContact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407
 Email: support@compliance4All.com\n\nFor more information visit https:
 //medtechiq.ning.com/events/the-value-of-a-human-factors-program
DTSTART;TZID=America/New_York:20180112T100000
DTEND;TZID=America/New_York:20180112T110000
CATEGORIES:online
LOCATION:Fremont
WEBSITE:http://www.compliance4all.com/control/w_product/~product_id=50
 1638LIVE?channel=medtechiq_Jan_2018_SEO
URL:http://www.compliance4all.com/control/w_product/~product_id=501638
 LIVE?channel=medtechiq_Jan_2018_SEO
CONTACT:18004479407
ORGANIZER:Event Manager
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562032532?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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