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SUMMARY:Webinar on Rational Predictions for FDA inspections
DESCRIPTION:Overview: The webinar covers factors considered by FDA bef
 ore, during and after an inspection that can be used to predict your i
 nspectional vulnerability. Once you know some key points, you will see
  that FDA's approach to inspections follows well-established procedure
 s and risk criteria that enables FDA to characterize your firm's compl
 iance. Usually the only way FDA will let you know about your profile i
 s when an official action is indicated. That is not a good thing. Othe
 rwise, you hear very little and even then, you may wait a long time. T
 he cloud of doubt can plague a firm for months.\nWhy Should you Attend
 :\nFDA's inspectional program is more predictable once you understand 
 FDA's inspection selection criteria and the procedures used to conduct
  inspections. If you apply basic risk and public health concepts, the 
 handwriting on the wall becomes clearer about the likelihood of an ins
 pection. From an investigator's point of view, a firm's war room activ
 ity seems like a sequel to Shakespeare's play, \"Much Ado about Nothin
 g.\"\nThe investigators thinking and actions typically follow predicta
 ble directions and are usually based on information you already know. 
 Whether or not an investigator will find your Pandora's Box of problem
 s requires some skill in interpreting the first and second phase of an
  inspection. Firms are thinking along the lines of \"Are they getting 
 hot? Are they getting cold?\" How can you tell? That actually is diffi
 cult to determine unless you identify the patterns in the investigator
 's work. Finally, firms invariably ask the investigator at the end of 
 an inspection, \"So how did we do?\" You will not get an answer, but i
 f you know how to read a list of inspectional observations noted on FD
 A's Form 483 (483), you can have a good idea.\nAreas Covered in the Se
 ssion:\nFDA's annual work plan criteria for inspectionsFDA's inspectio
 nal training and standard proceduresEvidence development strategyWar r
 oom hysteriaInspection classification by FDA and follow up\nWho Will B
 enefit:\nRegulatory Affairs Directors / ManagersCorporate legal counse
 lFDA consultantsManufacturing ManagersQuality Assurance Managers\nSpea
 ker Profile:\nCasper (Cap) Uldriks, through his firm “Encore Insight
  LLC,” brings over 32 years of experience from the FDA. He specializ
 ed in the FDA’s medical device program as a field investigator, serv
 ed as a senior manager in the Office of Compliance and an Associate Ce
 nter Director for the Center for Devices and Radiological Health. He d
 eveloped enforcement actions and participated in the implementation of
  new statutory requirements. His comments are candid, straightforward 
 and of practical value. He understands how FDA thinks, how it operates
  and where it is headed. Based on his exceptionally broad experience a
 nd knowledge, he can synthesize FDA’s domestic and international ope
 rational programs, institutional policy and thicket of legal variables
  into a coherent picture. Professional credentials: JD – Suffolk Uni
 versity, licensed in Massachusetts and the District of Columbia; M.Div
  in psychology – Boston University with internship through Harvard U
 niversity.\nContact Detail:\nNetZealous - Compliance4All,161 Mission F
 alls Lane, Suite 216,Fremont, CA 94539, USA.Phone: +1-800-447-9407Emai
 l: support@compliance4All.comhttp://www.compliance4all.com/Event Link 
 : http://bit.ly/1GwxA9r\n\nFor more information visit https://medtech
 iq.ning.com/events/webinar-on-rational-predictions-for-fda-inspections
DTSTART;TZID=America/New_York:20151215T100000
DTEND;TZID=America/New_York:20151215T110000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:
URL:
CONTACT:8004479407
ORGANIZER;CN="Adam Fleming":https://medtechiq.ning.com/profile/Complia
 nce4all
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 file/get/2562012364?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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