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DTSTART:19700308T020000
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DTSTAMP:20260519T063155Z
SUMMARY:Meet FDA Expectations for a Tougher Supplier Audit Program
DESCRIPTION:Overview:\nThere is a pervasive public perception that the
  FDA has been ineffective in protecting the public. Recent news events
  seem to support this perception. The FDA is working hard to change th
 at perception.Industry must be prepared to adapt, and recognize that s
 uch adaptation will actually work to their long-term benefit. This web
 inar will discuss and evaluate the effects that this call for change h
 as on a company and its selection, audit, use and on-going relations w
 ith its suppliers of services and products / components. How can compa
 nies address the FDA's stated desire to require \"on-site\" audit of a
 ll Pharma suppliers? Expectations for meaningful, results driven actio
 ns that addresses and resolve any underlying compliance issues or prod
 uct problems are increasing among regulatory agencies worldwide. To me
 et the new regulatory climate and be competitive, companies need to re
 evaluate their vendors and the methods used in selecting, evaluating, 
 auditing, retaining or cutting adrift such regulatory \"partners\".Why
  you should attend: The last few years have seen the U.S. FDA come un
 der increasing negative public scrutiny. High profile drug recalls, fo
 od chain problems and contamination, import problems, resignations. No
 w a new commissioner vows no more \"business as usual\". Data in submi
 ssions and decisions rendered will be more science based. Most Warning
  Letters will not have an initial judicial review, resulting in more a
 nd faster Warning Letter filings. Larger, higher profile companies are
  coming under FDA investigation activities. Companies are outsourcing 
 more; with some thinking they can also outsource some of their cGMP co
 mpliance as well. Thus, the U.S. FDA has indicated that a key area gai
 ning attention is a company's suppliers, for services and products / c
 omponents. Why needed? FDA expectations? How are successful companies 
 meeting this challenge? Tools that need to be put in place or enhanced
 . Meeting the challenges of more \"on site\" audits. Getting supplier 
 buy-in. Coping with \"rogue\" suppliers.Areas Covered in the Session:\
 n\nRegulatory \"Hot Buttons\"\nClassify suppliers; Supplier requiremen
 ts by \"classification\"\nWhat's behind the COA? The COC?\nThe FDA's i
 ncreasing emphasis on the site audit \nTypes of remote audits\nMainta
 ining the relationship\n\nWho Will Benefit:\n\nSenior management in Dr
 ugs, Devices, Biologics, Dietary Supplements \nQA\nRA\nR&D\nEngineeri
 ng\nProduction\nOperations\nConsultants; others tasked with project le
 adership responsibilities\n\nCLICK HERE\n\nFor more information visit 
 https://medtechiq.ning.com/events/meet-fda-expectations-for-a-tougher-
 supplier-audit-program
DTSTART;TZID=America/New_York:20140702T100000
DTEND;TZID=America/New_York:20140702T113000
CATEGORIES:seminar, pharma, medical, clinical, health, compliance, reg
 ulatory, fda
LOCATION:Online Event
WEBSITE:http://bit.ly/1nop4ze
URL:http://bit.ly/1nop4ze
CONTACT:8004479407
ORGANIZER:GlobalCompliancePanel
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562011671?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob
 inson":https://medtechiq.ning.com/profile/JohnRobinson
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