2600 E. Bayshore Road
Palo Alto, California 94303

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.

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?

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

Added by complianceonlinecom on June 29, 2012