ComplianceOnline

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

Instructor: Gerry O Dell
Product ID: 703288
  • Duration: 60 Min

recorded version

$279.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$379.00
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CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

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

  • 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
Instructor Profile:
Gerry O Dell

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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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