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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 explains what actions should be taken following a
 n unexpected positive result in a&nbsp\;sterility&nbsp\;test on a biologi
 cal indicator (BI) during performance qualification or routine testing. I
 t also addresses the actions to take when a test of&nbsp\;sterility&nbsp\
 ;demonstrates unexpected growth during validation or routine dose audits.
  The various items that should be investigated to determine the root caus
 e and the follow up to the investigation will be covered.\n\nWhy Should Y
 ou Attend:\n\nAll sterile products require some level of&nbsp\;sterility&
 nbsp\;during validation and then during routine production. What actions 
 your company takes when this testing exhibits results that do not meet ex
 pectations or specifications can be critical from a regulatory and safety
  standpoint. You need to know what and how to investigate these potential
  failures or out-of-specification conditions to identify the root cause. 
 You also need to know if the failure impacts product release\, do you nee
 d to recall product\, is your validation okay\, and are there any actions
  that can be taken to prove there is no product impact.\n\nThis presentat
 ion will review the various items that should be investigated to determin
 e the root cause when a failure occurs during\n\n\na&nbsp\;sterility test
  for biological indicators&nbsp\;during validation or routine processing 
 for EO sterilization processes.\na&nbsp\;test of sterility&nbsp\;followin
 g a verification dose either initially or during a dose audit.\n\nIt will
  also cover the actions to be taken as a follow up to the investigation.\
 n\nAreas Covered in the Webinar:\n\n\nIs this result really a failure tha
 t needs to be investigated?\nWhat items are important to investigate duri
 ng sterilization process validation?\nIf a failure occurs during&nbsp\;st
 erilization process validation&nbsp\;what actions can you take?\nThe lab 
 says the routine process BI is positive\, what now?\nMy dose audit did no
 t pass\, what does that mean?\n\nWho Will Benefit:\n\nThis webinar will p
 rovide valuable information to all companies that produce sterile medical
  devices. The following personnel will benefit:\n\n\nQA personnel\nValida
 tion specialists\nManufacturing personnel involved in validations\nR&amp\
 ;D specialists\n
DTEND:20250311T111500
DTSTAMP:20260512T213555Z
DTSTART:20250311T100000
LOCATION:\,
SEQUENCE:0
SUMMARY:This webinar explains what actions should be taken following an un
 expected positive result in a&nbsp\;sterility&nbsp\;test on a biological 
 indicator...
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