This highly interactive 3-day, advanced course 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 opportunity to apply what they learn to actual sterilization scenarios.

Course Objectives
Upon completion of this course, 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.

Topics to be Covered

• Validation and Requalification
• Validation Reports, Protocols, and Documentation
• Product Adoption
• Troubleshooting
• Process Changes and Process Equivalency
• Product Release Methods
• Optimization of Sterilization Process

Program At-A-Glance
This 3-day course will be held from 8:00 am - 5:00 pm each day. A detailed course schedule will be available in early 2008. Please check back for program updates.

Who Should Attend?
This program 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 course for those who are experienced in working with an established ethylene oxide sterilization process and NOT professionals that are new to ethylene oxide sterilization.

Dates and Hotels

DATE LOCATION FACTS October 20-22 , 2008 The Westin Arlington Gateway * 801 North Glebe Road Arlington, VA 22203 Web site 888-627-7076 / 703-717-6200 $199 single/double rate through Sep 22, 2008 NOTE: Reservation requests should be made as soon as possible, but no later than the"rate through" date listed above. Rooms are assigned on a first-come, first-served basis and may sell out prior to the deadline. * Due to the number of events that AAMI is holding at The Westin Arlington Gateway in 2008, it is necessary to specify which course you are attending when making your room reservation.

Faculty
Course faculty are drawn from an experienced group of quality systems professionals. All course 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.

Course Materials
As part of the course materials, attendees receive a copy of the ANSI/AAMI/ISO 11135 series on ethylene oxide sterilization standards and the following technical information reports:

• Ethylene oxide contract sterilization
• Ethylene oxide sterilization equipment, process considerations, and pertinent calculations
• Process development and performance qualification for ethylene oxide sterilization - microbiological aspects
• Parametric release for ethylene oxide sterilization
• Product adoption and process equivalency for ethylene oxide sterilization

Registration Fees
Fee includes all course materials and continental breakfast, lunch, and refreshment breaks for three days.

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