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Bali Technical & Engineering

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)

Form Pre-Registrasi

	Data Materi Training
Topik Training	: Cleaning Validation
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