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

This webinar on sterility or bioburden test for medical devices will discuss about the various items that should be investigated to determine the root cause, when a failure occurs during a sterility test, and the follow up to the investigation.

Why Should You 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. You need to know what and how to investigate during these potential failures or out-of-specification conditions to identify the root cause.

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.

For Registration:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701503?channel=ScienceDZ