Validation and Use of Excel Spreadsheets in FDA Regulated Environments 2017 is a webinar that covers topics such as:
- 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
Validation and Use of Excel Spreadsheets in FDA Regulated Environments 2017 is intended for:
- QA Managers and Personnel
- Everybody developing Excel Worksheets for regulated environments
- Analysts and Lab Managers
- QC Managers and Personnel
- Validation Professionals
- Validation Groups
- Documentation Department
- Training Departments
- Consultants
