Topics
- The Part 11 requirements for electronic records
- The QSR requirements for computers in production or the quality system
- FDA Guidance documents and their expectations
- Utilizing Excel`s built in data validation methods
- Writing validation protocols and reports for Excel spreadsheet
Who should Attend
Medical Device professionals including Production and Process Engineers, Design Engineers, Validation specialists, Quality Engineers, Quality Auditors, Quality Managers and Quality staff assigned to Customer Complaints or CAPA management.
