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UID:2140535:Event:195730
DTSTAMP:20260605T004530Z
SUMMARY:A straightforward method for meeting FDA Requirements for Desi
 gn Inputs and Outputs
DESCRIPTION:Overview\n\nA robust DIOM can serve as the foundation for 
 meeting FDA requirements and is a useful tool to ensure future iterati
 ons, changes, and re-visits to the initial design are clearly document
 ed. A DIOM ensures design information is clearly presented, well-docum
 ented, and most importantly, located within one simple document. This 
 webinar provides a simplistic tool to help identify and categorize des
 ign inputs, determine the most effective method in providing design ou
 tput evidence, and showing traceability to all activities associated w
 ith both.\nThe speaker has worked on numerous design development proje
 cts in Class II and Class III medical devices as well as establishing 
 Quality Management Systems which include easy-to-understand methods to
  meet design development and design control requirements. This webinar
  will walk you through step-by-step how to complete a DIOM for your pr
 oduct and simplify this often overly complex process.\n\nWhy should yo
 u Attend\n\n\nBetter understanding of FDA regulations with regards to 
 design input and output\nAn organized approach in meeting design input
  and output requirements\nA simplified way to ensure design inputs and
  outputs are continually maintained and tracked\n\n\nAreas Covered in 
 the Session\n\n\nIntroduction to the DIOM template\nHow to identify yo
 ur design inputs\nHow to categorize your design inputs and their sourc
 es\nWays in which design inputs can be verified\nCommon documents and 
 activities used as design output evidence\nAdditional requirements of 
 design inputs and outputs\n\n\nWho Will Benefit\n\n\nQuality Assurance
 \nRegulatory Affairs\nDesign Engineers\nManufacturing Engineers\nStart
 up Companies\n\n\nSpeaker Profile\n\nDenise Wrestler ASQ CQE, CQA; QA
 /RA Consultant at CYA Medical Device Consulting, LLC with almost 15 ye
 ars of experience within FDA-regulated industries including medical de
 vice and pharmaceuticals, Ms. Wrestler provides quality, regulatory, a
 nd technical expertise to meet individual client needs. Ms. Wrestler a
 grees with the FDA's \"least burdensome approach\" and prides herself 
 on providing options and recommendations for ensuring regulations are 
 met without wasting precious company resources. \n\n\nFor more inform
 ation visit https://medtechiq.ning.com/events/a-straightforward-method
 -for-meeting-fda-requirements-for-design
DTSTART;TZID=America/New_York:20191118T100000
DTEND;TZID=America/New_York:20191118T113000
CATEGORIES:webinar
LOCATION:Fremont, CA
WEBSITE:http://www.traininng.com/webinar/the-diom---a-straightforward-
 method-for-meeting-fda-requirements-for-design-inputs-and-outputs--201
 074live?medtechiq-Nov-Seo-2019
URL:http://www.traininng.com/webinar/the-diom---a-straightforward-meth
 od-for-meeting-fda-requirements-for-design-inputs-and-outputs--201074l
 ive?medtechiq-Nov-Seo-2019
CONTACT:(510) 962-8903
ORGANIZER;CN="Joseph Wilcox":https://medtechiq.ning.com/profile/Joseph
 Wilcox
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/1223597505?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Joseph W
 ilcox":https://medtechiq.ning.com/profile/JosephWilcox
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