Samin
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Detailed Analysis
Samin approaches his inspections by giving a thorough look at every aspect of production, from initial component checking to final product release. He is specifically rigorous about testing and cleanliness standards.
FDA Auditor Samin is keenly interested in the areas of Stability Testing Program, Contamination Prevention, Sterility Procedures, Equipment Cleaning, Batch Testing, In-Process Control Procedures, Microbial Testing of Components, Potency Testing, Instrument Calibration, and Cleaning and Sanitation of Equipment.
- Data Integrity
- Quality Risk Management
- Computer System Validation
- Equipment Qualification
- Complaint Management
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