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Live Webinar

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Troubleshooting Ethylene Oxide (EO) Processes

Date & Time: Thursday, December 15, 2011

10:00 AM PST | 01:00 PM EST

Duration: 90 Minutes

Instructor: Gerry O'Dell

Location: Online

Price : $245.00

 

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(for one participant)

Instructor Profile:

Overview:

Gerry O'Dell President, Gerry O’Dell Consulting

Not every parameter in the EO sterilization process in critical for the determination of the SAL. This presentation will outline the various parameters and what actions should be taken when they are not compliant to the process specification. These actions may be as simple as a rationale for release to as complicated as the need for the qualification of a new sterilization process. How to decide the course to take will be addressed along with the reasons behind the decisions so that an accurate and complete justification of your decision can be made for both management and regulatory agencies. The rationales for both conventional and parametric release will be addressed.

Why you should attend: Ethylene oxide (EO) sterilization is the most complicated of the industrial sterilization methods. It is not uncommon for anomalies to occur during qualification or routine processing. These anomalies may come in the form of sterilization cycle parameter that is not achieved or a positive biological indicator.

Areas Covered in the Session:

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What is a cycle anomaly What cycle specifications are critical for sterilization What cycle specifications are critical for product residuals Actions to be taken for critical deviations/anomalies Actions to be taken for non-critical deviations/anomalies What testing can be performed to justify product release Developing a specification to address actions

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How to document your rationale

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Gerry O’Dell, is President of Gerry O’Dell Consulting, a consulting firm based in the United States with clients around the world. Gerry O’Dell consults to medical device and pharmaceutical companies related to all the major sterilization methodologies, microbiology, environmental control, laboratory compliance, failure investigation, etc. Her varied background includes extensive knowledge in sterilization technology, laboratory management, microbiological testing, and compliance. Prior to starting Gerry O’Dell Consulting, she worked for Johnson & Johnson and has over twenty-five years of experience in the medical device industry. Gerry is a Registered Microbiologist with the National Registry of Microbiologists in the area of Consumer Products & Quality Assurance. Gerry is actively involved in the development of sterilization standards and is currently Co-Chair of the AAMI Industrial Ethylene Oxide Sterilization Working Group. ...more

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This webinar will provide valuable information to all companies that produce sterile products

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QA personnel Validation specialists Manufacturing personnel involved in validations

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R&D specialists

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It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel

About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning


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Troubleshooting Ethylene Oxide (EO) Processes  

Ethylene oxide (EO) sterilization is the most complicated of the industrial sterilization methods. It is not uncommon for anomalies to occur...

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