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SUMMARY:FDA Warning Letter Closeout Program
DESCRIPTION:This FDA warning letter closeout program will discuss how 
 to successfully complete warning letter close out program which will h
 elp firm to obtain a closeout letter from FDA.\n\nWhy Should You Atten
 d:\nFDA Commissioner Margaret Hamburg recently announced several new e
 nforcement initiatives. Part of the \"new FDA\" is the increased issua
 nce of warning letters and the creation of a warning letter \"closeout
 \", which regulated firms can use to your advantage.\nFDA's warning le
 tter program has changed substantially and more warning letters will b
 e issued - and faster! In the past, firms that received a warning lett
 er from FDA were subject to unending scrutiny, speculation and financi
 al challenge. But now warning letter recipients will have the chance t
 o prove they are back in compliance. FDA will provide a manner for a f
 irm to demonstrate that it has complied with the terms of an enforceme
 nt action. The warning letter closeout program has begun as of Septemb
 er 2009. All firms who receive a warning letter will have the opportun
 ity to obtain a \"closeout\" letter from FDA. Firms that fail to obtai
 n a closeout letter will be clearly identified as still being under FD
 A scrutiny.\nAttend this Webinar to know everything about warning lett
 ers, warning signs, issuance, company’s response and how to rectify 
 the FDA warning letter close out mistakes.\nAreas Covered in the semin
 ar:\n\nOutline of FDA enforcement and compliance scheme.\nFDA inspecti
 on process.\nLead up to a warning letter - warning signs.\nWarning let
 ter issuance.\nCompany response to FDA warning letters.\nWhat to avoid
  when dealing with FDA warning letters.\nCorrecting FDA warning letter
  closeout mistakes.\n\nWho will benefit:\nThis seminar will give valua
 ble help to FDA regulated Pharmaceutical, Medical Device, Biotech, Dia
 gnostics and Biological manufacturers who have received, expect or fea
 r an FDA-483 or Warning Letter. The staff members who will benefit inc
 lude:\n\nVP of Quality\nDirector of Quality\nCEO, COO, President and o
 ther operating executives\nBoard of Directors\nQuality managers and pe
 rsonnel\nInternal auditors\nConsultants\n\n\nFor more information visi
 t https://medtechiq.ning.com/events/fda-warning-letter-closeout-progra
 m
DTSTART;TZID=America/New_York:20131205T100000
DTEND;TZID=America/New_York:20131205T110000
CATEGORIES:fda, compliance
LOCATION:Online Event
WEBSITE:http://www.complianceonline.com/ecommerce/control/trainingFocu
 s/~product_id=701521?channel=meditechiq
URL:http://www.complianceonline.com/ecommerce/control/trainingFocus/~p
 roduct_id=701521?channel=meditechiq
CONTACT:+1-650-620-3915
ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer
 ral512
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562006613?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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