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Validation – Spreadsheets

In this course, the student will learn the FDA requirements for spreadsheet validation. We discuss topics such as:

  • Regulatory Requirements
  • FDA Internal Guidelines
  • User Requirement Specification
  • Design Specification
  • Validation
  • Spreadsheet Design
  • Examples
  • Managing Spreadsheets
  • Common Spreadsheet Problems
  • 483's and Warning Letters
Examples are discussed during the course, and there will be plenty of time for questions and discussion.