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DTSTAMP:20260522T165805Z
SUMMARY:483 Covers a Broad Gradation of Problems
DESCRIPTION:Overview:How you respond to the 483 should provide the fou
 ndation for any future communication with the FDA about a particular i
 nspection. Understanding how FDA organizes its evaluation of the 483 c
 an facilitate the FDA’s review in your favor as it is well organized
 , succinct and provides proper documentation.\nWhy You Should Attend:Y
 our failure to understand and properly respond to a 483 issued to you 
 at the conclusion of an FDA inspection may quickly lead to an administ
 rative or a legal action that can have an immediate adverse effect on 
 a firm’s business.\nAreas Covered in the Session:What the 483 meansH
 ow to interpret the 483 - \"How bad is it?\"Managing the 483 discussio
 n with the FDA at the conclusion of the inspectionResponding to the FD
 A in writing\nWho Will Benefit:ManufacturersFDA ConsultantsLegal Couns
 elRegulatory Affairs ManagersQuality Assurance Staff\nSpeaker Profile:
 Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” bring
 s over 32 years of experience from the FDA. He specialized in the FDA�
 ��s medical device program as a field investigator, served as a senior
  manager in the Office of Compliance and an Associate Center Director 
 for the Center for Devices and Radiological Health.\nContact Detail:Co
 mpliance4All DBA NetZealous,Phone: +1-800-447-9407Email: support@compl
 iance4All.com\n\nFor more information visit https://medtechiq.ning.com
 /events/483-covers-a-broad-gradation-of-problems
DTSTART;TZID=America/New_York:20171025T100000
DTEND;TZID=America/New_York:20171025T113000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://www.compliance4all.com/control/w_product/~product_id=50
 1516LIVE?channel=medtechiq_Oct_2017_SEO
URL:http://www.compliance4all.com/control/w_product/~product_id=501516
 LIVE?channel=medtechiq_Oct_2017_SEO
CONTACT:18004479407
ORGANIZER:Event Manager
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562014914?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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