Curriculum
- 7 Sections
- 30 Lessons
- 1 Day
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- Introduction to Validation5
- 1.1Definition and importance of validation in regulated industries
- 1.2Key validation types: Process, Cleaning, Equipment, and Computer System Validation (CSV)
- 1.3Overview of international regulatory standards (e.g., FDA, EU, ICH, WHO)
- 1.4Lifecycle approach to validation
- 1.5Activity: Quick quiz to assess participants’ baseline understanding
- Validation Master Plan (VMP)5
- Key Validation Documents4
- Practical Considerations in Validation Execution4
- 4.1Challenges in validation execution (e.g., deviations, data integrity)
- 4.2Handling validation deviations and CAPA (Corrective and Preventive Action)
- 4.3Tools and technologies in validation management
- 4.4Simulation: Perform a mock validation activity, including deviation handling and corrective action planning
- Risk-Based Validation Approach4
- Regulatory Compliance and Validation Audits4
- Emerging Trends and Innovations in Validation4