Responding to a Dose Audit Test Failure
Instructor:
Gerry O Dell
Product ID: 705934
- Duration: 60 Min
Why Should You Attend:
All irradiated products require dose auditing to demonstrate maintenance of the sterilization dose. At times the audit results might indicate that the dose needs to be augmented or that the dose must be re-established. Prior to or in conjunction with these actions an investigation is required to determine the potential root cause of the failure. This investigation and assessment must be performed in a well thought out manner covering all aspects since the results could mean that a field action is warranted. It is critical to know what and how to investigate these potential failures 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 Webinar:
- Is this result really a failure?
- What items are important to investigate?
- The dose audit did not pass, can the dose be augmented?
- What can be done to re-establish the dose?
- How to establish the boundaries of product that is impacted by the failed audit
- How to address and assess product in the field?
Who Will Benefit:
This webinar will provide valuable information to all companies that produce sterile medical devices.
- QA personnel
- Validation
- Manufacturing personnel
- R&D
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. Her over 35 years of experience in all the major sterilization methods, microbiology, environmental control, laboratory compliance, failure investigation, has enabled Gerry to successfully consult to companies ranging from small start-up operations to Fortune 500 companies. She has also played a significant role in sterilization standards development for over 25 years through her association with the American Association for the Advancement of Medical Instrumentation (AAMI).
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