Registration Industrial Ethylene Oxide Sterilization for Medical Devices Workshop
This highly interactive 3 day, advanced workshop assumes that participants are experienced in working with an established ethylene oxide sterilization process, but are now challenged with ensuring the continued effectiveness and assessing change for the product or process. The program combines classroom lecture with real life scenarios to illustrate concepts and situational analyses that provide participants with the opportunity to apply what they learn to actual sterilization scenarios.
Workshop ObjectivesUpon completion of this workshop, participants will be able to:
- Improve development and routine turn-around time
- Make changes to product, equipment, process, and sterilizer location
- Determine if validation or requalification is necessary
- Troubleshoot cycle anomalies
- Optimize the ethylene oxide sterilization process
| Program At-A-Glance | |
| DAY ONE TO THREE - 8:00 AM - 5:00 PM | |
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Who
Should Attend?
This workshop is designed for professionals that have responsibility for making decisions related to the ethylene oxide sterilization process such as introduction of new/modified products, sterilization process improvements, failure investigation, requalification, and validation. AAMI recommends this workshop for those who are experienced in working with an established ethylene oxide sterilization process and NOT professionals that are new to ethylene oxide sterilization.
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Workshop faculty are drawn from an experienced group of quality systems professionals. All faculty have completed an instructor training program to ensure consistency and quality from session to session. The mix of industry leaders, consultants, and FDA personnel helps to ensure a balanced presentation of the requirements and paths to compliance.
Workshop Materials
- The standard, ANSI/AAMI/ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- Technical information reports on product adoption and process equivalency for ethylene oxide sterilization and the application of ANSI/AAMI/ISO 11135-1
Fees and Registration
Fees include participant notebook of workshop materials and case studies; relevant standards and technical information reports; pertinent FDA documents and additional references; and continental breakfast, lunch, and refreshments. Click here to go to registration.
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