Cleaning Validation

MATERI 1. Regulatory Requirements for Cleaning Validation 2. Goals of Cleaning: Risk and Science 3. Risk Assessment: Risk Identification 4. Risk Assessment: Risk Analysis 5. Risk Assessment: Risk Evaluation 6. Risk Control: Risk Reductio 7. Method Validation and Recovery Studies 8. Documentation for Cleaning Validation 9. Risk Review and Risk Communication 10. Risk-Based Approach to Cleaning Development and Verification

• Risk and Hazard Identification
• Science-Based and Risk-Based Limits

13. Risk Analysis

• Cleaning Process Risk Analysis and Process Development
• Cleaning Equipment Design and Qualification
• Cleaning Control Strategy
• Sampling
• Analytical Methods for Assessment of Cleaning

14. Risk Analysis of Cleaning Procedures 15. Risk Evaluation

• Tools for Risk Analysis in Cleaning
• FMEA/FMECA
• Risk-based Analysis of Cleaning Data
• Risk Analysis Master Planning
• Assessment and Monitoring
• Risk Control
  • PAT approaches to Cleaning Validation
  • Periodic Assessment and Monitoring

16. Risk Review 17. Risk Communication TRAINING METHOD Presentation Discussion Case Study Evaluation FACILITY Training Kit Handout Certificate Lunch + 2x Coffee Break Souvenir Pick Up Participant (Yogyakarta) PELATIHAN LAINNYA