You have a BI Positive or Product Sterility Positive - Now What?

Why Should You Attend:

All sterile products require some level of sterility during validation and then during routine production. What actions your company takes when this testing exhibits results that do not meet expectations or 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 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.
• a test of sterility following a verification dose either initially or during a dose audit.

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?

Who Will Benefit:

This webinar will provide valuable information to all companies that produce sterile medical devices. The following personnel will benefit:

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

Gerry O Dell
President, Gerry O’Dell Consulting

Gerry O'Dell, is Co-owner and Technical Director for O'Dell & Hodge Consulting, LLC a consulting firm based in the United States with medical device and pharmaceutical clients around the world. She spent approximately 26 years consulting to companies of all sizes assisting them to comply with requirements at all stages of the development and manufacturing process for any sterilization modality. Then in 2024 she joined with Samantha Hodge to form O'Dell & Hodge Consulting and continues to consult in the realm of sterilization and microbiology. Prior to consulting Gerry worked for Johnson & Johnson as a 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. She holds both a Bachelor and Master of Science degree in Microbiology from the University of South Florida and has over 41 years of experience in the medical device industry.

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