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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.\nWhy Should You Attend:
 \nFDA Commissioner Margaret Hamburg recently announced several new enf
 orcement initiatives. Part of the \"new FDA\" is the increased issuanc
 e of warning letters and the creation of a warning letter \"closeout\"
 , which regulated firms can use to your advantage.\nFDA's warning lett
 er program has changed substantially and more warning letters will be 
 issued - and faster! In the past, firms that received a warning letter
  from FDA were subject to unending scrutiny, speculation and financial
  challenge. But now warning letter recipients will have the chance to 
 prove they are back in compliance. FDA will provide a manner for a fir
 m to demonstrate that it has complied with the terms of an enforcement
  action. The warning letter closeout program has begun as of September
  2009. All firms who receive a warning letter will have the opportunit
 y to obtain a \"closeout\" letter from FDA. Firms that fail to obtain 
 a closeout letter will be clearly identified as still being under FDA 
 scrutiny.\nAttend this Webinar to know everything about warning letter
 s, warning signs, issuance, company’s response and how to rectify th
 e FDA warning letter close out mistakes.\nAreas Covered in the seminar
 :\n\nOutline of FDA enforcement and compliance scheme.\nFDA inspection
  process.\nLead up to a warning letter - warning signs.\nWarning lette
 r issuance.\nCompany response to FDA warning letters.\nWhat to avoid w
 hen dealing with FDA warning letters.\nCorrecting FDA warning letter c
 loseout mistakes.\n\nWho will benefit:\nThis seminar will give valuabl
 e help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagn
 ostics and Biological manufacturers who have received, expect or fear 
 an FDA-483 or Warning Letter. The staff members who will benefit inclu
 de:\n\nVP of Quality\nDirector of Quality\nCEO, COO, President and oth
 er operating executives\nBoard of Directors\nQuality managers and pers
 onnel\nInternal auditors\nConsultants\n\nInstructor Profile:\nAlfonso 
 Fuller, is the founder and President of Fuller Compliance, a consultin
 g firm that specializes in FDA quality system, software quality and so
 ftware validation for pharmaceutical, biotech and medical device compa
 nies. Al is the author of several white papers, has spoken at numerous
  seminars, and has represented many clients before FDA compliance and 
 enforcement personnel, and actively consults on day-to-day compliance 
 issues.\n\n\n\nFor more information visit https://medtechiq.ning.com/e
 vents/fda-warning-letter-closeout-program-1
DTSTART;TZID=America/New_York:20131217T100000
DTEND;TZID=America/New_York:20131217T110000
CATEGORIES:food, healthcare
LOCATION:Online Event
WEBSITE:http://www.complianceonline.com/ecommerce/control/trainingFocu
 s/~product_id=701521?channe=medtechiq
URL:http://www.complianceonline.com/ecommerce/control/trainingFocus/~p
 roduct_id=701521?channe=medtechiq
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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