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. You also need to know if the failure impacts product release, do you need to recall product, is your validation okay, and are there any actions that can be taken to prove there is no product impact.

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

• During validation or routine processing for EO sterilization processes.
• During a test of sterility following a verification dose either initially or during a dose audit.
• When the product bioburden level exceeds the alert or action levels that have been established for the product.

It will also cover the actions to be taken as a 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?

For Registration:

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