You have a Sterility Failure or Bioburden Excursion - Now What? 2013

Topics

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

Who should Attend

• Validation specialists
• QA personnel
• R&D specialists
• Manufacturing personnel involved in validations