This webinar will discuss what actions should be taken following a positive result in a sterility test on a biological indicator (BI) during performance qualification or routine testing. It will also explain the various items that should be investigated to determine the root cause 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 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 webinar addresses the actions to take when a test of sterility demonstrates growth during validation or routine dose audits. It will review the various items that should be investigated to determine the root cause when a failure occurs during
It will also cover the actions to be taken as a follow up to the investigation.
Areas Covered in the Webinar:
Who Will Benefit:
This webinar will provide valuable information to all companies that produce sterile medical devices. The following personnel will benefit:
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session