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.