Sandra A Hughes
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Detailed Analysis
Investigator Hughes adopts a systematic and methodical approach during inspections. She emphasizes on meticulous verification of sterilization processes, thorough investigation of device failures and stringent adherence to MDR procedures, with a keen eye on the level and adequacy of documentation.
FDA investigator, Sandra A Hughes, is a meticulous auditor that often focuses on areas involving sterilization processes, device failure investigations, equipment nonconformance, and adherence to MDR procedures. She heavily emphasizes on the importance of correct documentation and shows a keen interest in procedural compliance and validation, sterilization, and product acceptance procedures.
- Environmental Monitoring
- Training Management
- Batch Records
- Contamination Control
- Equipment Cleaning
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