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You have a sterility or Bioburden test failure - Now what?

You have a sterility or Bioburden test failure - Now what?

Venue Name: Online Webinar
Country: United States of America
City: Palo Alto
Number of Attendees: Unknown
Webinar or Virtual Event: Yes
Keywords: QA personnel,Validation specialists,R&D specialists
Start Date of Conference:: 11-30-2009
End Date of Conference: 11-30-2009
Description of Conference: This Bioburden test Webinar/training will discuss on various items that should be investigated to determine the root cause and the follow up to the investigation.

Areas Covered in the seminar:

Is this result really a failure that needs to be investigated?
What items are important to investigate during sterilization process validation?
If a failure occurs during sterilization process validation what actions can you take?
The lab says the routine process BI is positive, what now?
My dose audit did not pass, what does that mean?
The periodic bioburden testing exceeded the established alert limit, what actions should be taken?
What do you do if the bioburden action limit is exceeded?
How to determine if the bioburden excursion has an impact to sterilization.

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