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This seminar will provide an overview of the requirements to validate EO sterilization. This is based on the international standard ISO 11135-1:2007. This standard was recently revised and the changes were significant. In this one hour seminar you will obtain a basic understanding of the principles, core requirements of the ISO standard as well as related standards and guidance. We will define how EO sterilization works, the equipment involved, major issues with product sterilization via EO, and the validation requirements. Routine process control and monitoring will be reviewed along with requirements to maintain the process effectiveness.
Why should you attend:
Sterilization validation is a topic that results in many audit observations from the FDA and international regulatory bodies. Proper understanding of the principles and requirements of the related standards is crucial to proper compliance. In addition, understanding the requirements and integrating them early in the product design can lead to quicker time to market. This seminar will help RA/QA staff understand the basic principles as well as the standards and regulations. This will be useful when reviewing validation plans, performing internal audits and dealing with regulators. It is also beneficial to R&D staff to understand the requirements so they may be incorporated into the design inputs correctly.
Areas Covered in the Session:
- Introduction
- Terminology / Definitions
- EO characterization / effectiveness
- Process Equipment
- Product and Material Issues
- Process Definition
- Validation IQ/OQ/PQ
- Documentation, review and approval of validation
- Routine Monitoring
- Product Release
- Maintenance of process effectiveness
Who Will Benefit:
- RA Directors, Managers and Staff
- QA Directors, Managers and Staff
- Internal Audit Staff
- R&D Directors, Managers and Staff