Irina Gaberman
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Detailed Analysis
Irina Gaberman primarily focuses on vetting the individual stages of the manufacturing process, and how well each stage adheres to established procedures. She also looks for proper documentation of all activities and is keen on spotting inconsistencies, unjustified deviations, or compromises on sterility and cleanliness.
Irina Gaberman is an FDA auditor who displays an exhaustive interest in cleanliness, sterility procedures, detailed documentation and equipment maintenance. She tends to look for established procedures indicating rigorous handling and processing controls, and verifies how closely they are adhered to during manufacturing processes. Irina's reports suggest a preference for consistency in control mechanisms and 'on-ground' technique rather than merely inspecting paper documentation.
- Data Integrity
- Batch Records
- Document Management
- Contamination Control
- Cleaning Validation
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