Application of CAPA to the Device Sterilization Process 2012

Key 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.