Topics
- Introduction to Corrective & Preventive Action - CAPA
- Why CAPA
- Applicable Regulation & Standards
- Root Cause Determination
- When does a deficiency require CAPA?
- CAPA Tools & Methodology
- Actions to Prevent Recurrence
- Introduction to Industrial Sterilization
- Radiation Sterilization & Validation
- EO sterilization and Validation
- Contract Sterilization
- Workshop
- Utilizing CAPA tools to solve typical quality deficiencies
- Utilizing CAPA tools to solve sterilization deficiencies
- Instructors will lead attendees through several ‘real case’ exercises related to CAPA and sterilization & quality deficiencies; attendees will present findings to the rest of the group
Who should Attend
Personnel in Medical Device Manufacturing and Sterilization facilities, including CAPA Team Members, QA Personnel, Quality Engineers, SA Personnel, Anyone with direct hands on experience with sterilization & troubleshooting and Operations Managers.
