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PRODID:-//github.com/rianjs/ical.net//NONSGML ical.net 4.0//EN
VERSION:2.0
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DESCRIPTION:This webinar will include a detailed discussion of Contract Ma
 nufacturing Organizations (CMO) Quality Agreement topics such as change c
 ontrol\, documentation\, facilities and equipment\, lab controls\, sub-co
 ntracting\, etc. Attendees will learn how to comply with new FDA and EU g
 uidelines for contract drug manufacturers.\n\nWhy Should You Attend:\n\nC
 ontrol of suppliers such as Contract Manufacturing Organizations (CMO) ha
 s always been a requirement of the FDA and EU. With the issuance of these
  new regulatory documents the expectation is that there will be a written
  documentation of this control. Proof of this control can be presented to
  FDA / EU inspectors in the form of a Quality Agreement which is specific
  to a particular CMO.\n\nThis webinar will provide a thorough understandi
 ng of the content that is expected in Quality Agreement from a regulatory
  perspective. Each proposed section of a Quality Agreement is fully analy
 zed and suggested content is written with the new guidelines taken into c
 onsideration. Comparison of the two regulatory documents will be presente
 d with differences highlighted and discussed. The latest status of the FD
 A draft guidance will be discussed and a review of comments from industry
  is included.\n\nAreas Covered in the Webinar:\n\n\nThe who and what of a
  good Quality Agreement\nWhat a Quality Agreement is - and is not\nRespon
 sibilities of the owner vs. contract facility\nGMP responsibilities\nA co
 mparison of the new guidelines from the FDA and the EU\n\nWho Will Benefi
 t:\n\nThis webinar will provide valuable assistance to all personnel in:\
 n\n\nQuality Assurance\nExternal Manufacturing / Outsourcing\nQuality Aud
 iting\nTechnology Transfer\nRegulatory Affairs / Compliance\nSupply Chain
 \nPurchasing\nRisk Management\n
DTEND:20250115T110000
DTSTAMP:20260514T155835Z
DTSTART:20250115T100000
LOCATION:\,
SEQUENCE:0
SUMMARY:This webinar will include a detailed discussion of Contract Manufa
 cturing Organizations (CMO) Quality Agreement topics such as change contr
 ol\, docu...
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