2019 - Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

FDA and other agency’s requirements for spreadsheet validation - What do inspectors ask and what documents should be available.
How to design spreadsheets for Part 11/GxP/SOX/HIPAA compliance?
Validation during design, development, installation and on-going use.
When, what and how much to test?
Dealing with standard Excel functions: Recommendations from GAMP5.
How to ensure and validate spreadsheet integrity and security for GxP and Part 11?
How to apply risk based validation to spreadsheet applications?
Validation of 'ad hoc' spreadsheet applications.
How to document planning, specifications, installation, testing and changes?
Examples from manufacturing, laboratories and offices