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.Why You Should Attend:
All sterile products require some level of sterility and bioburden testing during validation and then during routine production. What actions your company takes when this testing exhibits results that do not meet specifications can be critical from a regulatory and safety standpoint.
This presentation will review the various items that should be investigated to determine the root cause when a failure occurs during a sterility test for biological indicators.You Will Learn:
Who Will Benefit:
- 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.
- QA personnel
- Validation specialists
- Manufacturing personnel involved in validations
- R&D specialists