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You have a Sterility Failure or Bioburden Excursion
Thursday, March 7, 2013 from 10:00 AM to 11:00 AM (PST)
Palo Alto, CA
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?
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.