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TZID:America/New_York
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TZNAME:EDT
DTSTART:19700308T020000
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BEGIN:VEVENT
UID:2140535:Event:82407
DTSTAMP:20260526T164213Z
SUMMARY:Device Changes, FDA Changes, and the 510(k)-2019
DESCRIPTION:Overview:Learn what approaches are required for product ch
 anges, for process changes, and Tracking and evaluating changes - the 
 \"tipping point\" , and how is the process risk-based?\nAreas Covered 
 in the Session:Is the process \"risk based\"?K-97-1 and the FDA's \"De
 cision Tree\"Documenting the process / rationaleResolving a \"wrong de
 cision\"\nWho Will Benefit:Senior Management, Project Leaders, Interna
 l / External ConsultantsRegulatory AffairsQuality Systems Personnel / 
 QAER&D and Engineering Staff\nSpeaker Profile:John E. Lincoln is a med
 ical device and regulatory affairs consultant. He has helped companies
  to implement or modify their GMP systems and procedures, product risk
  management, U.S. FDA responses.\nEvent Fee: One Dial-in One Attendee 
 Price: US$150.00\nContact Detail:Compliance4All DBA NetZealous,Phone: 
 +1-800-447-9407Email: compliance4all14@gmail.com\n\nFor more informati
 on visit https://medtechiq.ning.com/events/device-changes-fda-changes-
 and-the-510-k-2019
DTSTART;TZID=America/New_York:20190320T100000
DTEND;TZID=America/New_York:20190320T110000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://www.compliance4all.com/control/w_product/~product_id=5
 02271LIVE?channel=medtechiq_Mar_2019_SEO
URL:https://www.compliance4all.com/control/w_product/~product_id=50227
 1LIVE?channel=medtechiq_Mar_2019_SEO
CONTACT:Event Manager
ORGANIZER;CN="Adam Fleming":https://medtechiq.ning.com/profile/Complia
 nce4all
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/877058161?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
END:VEVENT
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