You have a BI or Sterility Failure - Now What?

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 Webinar:

• 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.

Who Will Benefit:

This webinar will provide valuable information to all companies that produce sterile medical devices.

• QA personnel
• Validation specialists
• Manufacturing personnel involved in validations
• R&D specialists

Gerry O Dell
President, Gerry O’Dell Consulting

Gerry O'Dell, is owner and President of Gerry O'Dell Consulting, a consulting firm based in the United States with medical device and pharmaceutical clients around the world. Prior to starting Gerry O'Dell Consulting, she worked for Johnson & Johnson Medical, Inc. as the Manager of Laboratory & Sterilization Services which managed the sterilization program for J&J Medical in addition to providing laboratory testing services to several J&J companies. Before becoming a part of Johnson & Johnson Medical, Gerry was Manager of Sterilization Services at Critikon, Inc where she started as a Lab Technician. She holds both a Bachelor and Master of Science degree in Microbiology from the University of South Florida and has over twenty-nine years of experience in the medical device industry.

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