Ileana Barreto-pettit
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Detailed Analysis
Ileana demonstrates a methodical approach with a strong preference for procedures that ensure sterility and prevent microbiological contamination. She favors data-supported justifications for processes and expiration dates and displays rigorous oversight of personnel hygiene standards.
FDA auditor Ileana Barreto-pettit exhibits a strong focus in the areas of sterility assurance and microbiological contamination prevention. Her observations indicate particular interest in the careful implementation and adherence to sterilization process validation, environmental monitoring systems, and personnel cleanliness protocols. She demonstrates rigorous scrutiny of a facility's sampling processes, contamination prevention procedures, and stability data. Her critique of cleaning and disinfection practices suggests an emphasis on the comprehensive quality management in drug production.
- Investigations
- Contamination Control
- Batch Records
- Equipment Qualification
- Filter Integrity Testing
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