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.
DAY ONE TO THREE - 8:00 AM - 5:00 PM
Upon 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
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.
Dates and Hotels
|Sep 18-20, 2013||The Hutton Hotel
1808 West End Avenue
Nashville, TN 37203
Rate through: 8/27/2013
|NOTE: Reservation request 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.|
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.
- 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
Fee includes PowerPoint presentations 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.
|AAMI corporate and institutional members||
|AAMI individual members||