Troubleshooting Ethylene Oxide (EO) Processes
Instructor:
Gerry O Dell
Product ID: 701679
- 13
- January 2025
Monday - 10:00 AM PT | 01:00 PM ET
Duration: 75 min
Why Should You 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 can come in the form of sterilization cycle parameter that is not achieved or a positive biological indicator. Not knowing how to respond to these situations can result in a response that results in the release of product that might not meet the required sterility assurance level (SAL) or the needless resterilization of product. Regulatory action can result from the former while additional expense to the company can result from the latter. Neither of these situations is of benefit to a manufacturer. This webinar will provide information on how to deal with these situations.
Areas Covered in the Webinar:
- 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
- How to document your rationale
Who Will Benefit:
This webinar will provide valuable information to all companies that produce sterile products.
- QA personnel
- Validation specialists
- Manufacturing personnel involved in sterilization
- 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.
More Training By Experts
- Ethylene Oxide (EO) Sterilization Basics for R&D Engineers
- Basics of Testing Associated with Sterilization Validation and Routine Processing
- You have a BI or Sterility Failure - Now What?
- How to Investigate Environmental Monitoring Excursions Limits
- Designing an Effective Cleaning Validation for Reusable Medical Devices in Today's Regulatory Environment
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).
