Cleaning Validation

Dilihat 792

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)