About Course
From regulatory expectations to health-based limits, sampling, methods and continued verification — plus five fully worked examples: FMEA, worst-case grouping, PDE → MACO → limits, recovery and Cpu, and bioburden/endotoxin hold times.
التحقق من صحة التنظيف — دورة فيديو تفاعلية بتعليق صوتي إنجليزي ونصوص ثنائية اللغة (إنجليزي / عربي).
Course modules
- Foundations and Regulatory Expectations
- Quality Risk Management for Cleaning
- Cleaning Process Design
- Acceptance Criteria and Health-Based Limits
- Sampling: Swab, Rinse and Recovery
- Analytical and Microbiological Methods
- Qualification and Continued Verification
- Equipment Design, Operations and Change Control
- Worked Example: FMEA for a Shared Line
- Worked Example: Worst-Case Grouping
- Worked Example: PDE → MACO → Swab, Rinse and TOC Limits
- Worked Example: Recovery Factors, Cpu and Control Limits
- Worked Example: Bioburden, Endotoxin and Hold Times
Instructor: Rafat Alghubari — GxPeria Founder & MD.
For education only — always follow the official guidance and your site procedures.
Course Content
Module 1: Foundations and Regulatory Expectations
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Foundations and Regulatory Expectations
09:35
Module 2: Quality Risk Management for Cleaning
Module 3: Cleaning Process Design
Module 4: Acceptance Criteria and Health-Based Limits
Module 5: Sampling: Swab, Rinse and Recovery
Module 6: Analytical and Microbiological Methods
Module 7: Qualification and Continued Verification
Module 8: Equipment Design, Operations and Change Control
Module 9: Worked Example: FMEA for a Shared Line
Module 10: Worked Example: Worst-Case Grouping
Module 11: Worked Example: PDE → MACO → Swab, Rinse and TOC Limits
Module 12: Worked Example: Recovery Factors, Cpu and Control Limits
Module 13: Worked Example: Bioburden, Endotoxin and Hold Times
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