Crystal Monroy
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Detailed Analysis
Crystal Monroy prioritizes thorough documentation and adherence to QA processes. The inspector adopts a methodical approach, rigorously verifying that all processes comply with validated standards. Monroy''s inspections often include a cross-check of past observations to ensure corrective actions have been implemented. The approach is highly detail-oriented, particularly regarding security measures and cleaning validation.
Crystal Monroy is a detail-oriented FDA auditor with a strong focus on validation and compliance, particularly in Quality Assurance (QA) processes. Monroy exhibits a consistent interest in ensuring that batch records are meticulously maintained and that QA approvals are appropriately documented. Monroy also prioritizes adherence to validated operating parameters and is stringent about security practices, especially concerning data integrity and access controls. The auditor has a keen eye for repeat observations, indicating a thorough follow-up practice to ensure corrective actions have been implemented. Monroy is also attentive to cleaning validation aspects to prevent cross-contamination, particularly involving OTC products and Class 2 Residual Solvents.
- Process Control
- Document Management
- Stability Studies
- Batch Records
- Supplier Quality Management
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