Topics
- Basic terms and definitions
- Introduction to Industrial Sterilization
- Documenting the EO Validation
- EO sterilization and Validation processes
- Typical deficiencies in the EO Process and Validation
- Maintaining EO Validation
- Radiation Sterilization and Validation processes
- Critical and noncritical deficiencies in the EO Process
- Process validation
- Determining sterilization dose
- Documenting the Radiation Validation
- Maintaining validated sterilization dose
- Critical and non critical deficiencies in the Radiation Process
- Typical deficiencies in the Radiation Process and Validation
- Introduction to CAPA
- When you should initiate CAPA with your contract sterilizer
- Why CAPA
- Applicable regulations and standards
- Determining Root Cause
- Defining when to move deficiency to CAPA
- CAPA tools
- Determining Actions to Prevent Recurrence
Who should Attend
CAPA team members, QA personnel, Quality Engineers, SA personnel and Operations Managers.
