Excel Spreadsheet Validation for FDA 21 CFR Part 11 - 2019

Topics

• Computer Systems Validation for Excel (will cover 21 CFR 11, Annex 11)
• Types and Uses of Excel Spreadsheets (e.g. disposable spreadsheets, spreadsheets used as documents, etc.)
• How to tailor your risk based methodology to Excel to determine the level of validation required
• Examples of Typical Approaches for Excel Validation

Who should Attend

• Directors of IT
• VP of IT
• Project Managers (for CSV / IT)
• Quality Managers
• Database Administrators
• Validation Specialists
• Directors /Senior Directors of Discovery
• System Administrators
• Directors /Senior Directors of Commercialization
• Directors /Senior Directors of Development
• Training Managers
• Document Managers
• Regulators