Topics
- Recommendations from the new GAMP®5 and EU Annex 11
- Regulatory requirements for spreadsheets; FDA Part 11, GxP, HIPAA, Sarbanes-Oxley
- How to ensure and validate spreadsheet integrity
- How to design spreadsheets for compliance
- Validation of standard/native Excel functions?
- When, what and how much to test?
- Validation of `ad hoc` spreadsheet applications
- How to apply risk based validation to spreadsheet applications
- Examples from manufacturing, laboratories and offices
- How to document planning, specifications, installation, testing and changes
Who should Attend
QA managers and personnel, Everybody developing and using Excel Worksheets for regulated environments, IT managers and personnel, QC managers and personnel, Validation groups, Analysts and lab managers, Training departments, Validation professionals, Consultants and Documentation department.
