This is the dummy course

Build an in-depth knowledge of validation through to latest GAMP® 5 guidance, and specific FDA regulatory requirements for 21 CFR Part 11 Electronic Records; Electronic Signatures from planning to reporting.

• Understand the FDA and EU Regulatory requirements
• Best practices for Instrument Qualification & Computer System Validation
• Overview of GAMP^® 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems
• The GAMP system lifecycle and specifications
• Validation & Control of Excel spreadsheets
• Quality Risk Management for computerized systems
• Revised EU Annex 11 Computerized Systems, including the official GAMP interpretation of key aspects
• FDA 21 CFR Part 11 Update, including the current FDA interpretation
• A Risk-based approach to Electronic Records and Signatures to meet both FDA and EU expectations