Program
Outline
DAY 1 | 8 AM-5 PM
Validation and Requalification
Protocols and Reports
DAY 2 | 8 AM-5 PM
Product Release Methods
Process Specifications
Troubleshooting
DAY 3 | 8 AM-5 PM
Ethylene Oxide Residuals
Optimization of Sterilization Process
DAY 4 | 8 AM-12 PM
Product Change
Process Changes / Equivalence
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Program
Objective
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; and optimize
the ethylene oxide sterilization process.
Target
Audience
This course 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.
Format
A combination of situation analyses, case
study exercises, and both formal and informal discussions are used throughout
the program to provide maximum opportunity for the application of information.
Materials
Fee includes presentations, pertinent FDA documents, additional references, and case
studies.
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