Heidy C Perales
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Detailed Analysis
Heidy C Perales employs a detail-oriented and systematic approach, prioritizing strict adherence to validation protocols and thorough documentation. She is proactive in identifying gaps in Quality Assurance oversight and insists on robust data security measures.
Heidy C Perales is a meticulous FDA investigator with a strong focus on both process validation and Quality Assurance practices. She places significant emphasis on adherence to validated parameters and thorough QA review and approval processes. She is also highly attentive to data security and user accountability, often looking for lapses in these areas. Her findings reveal a preference for stringent documentation and a zero-tolerance policy for non-compliance, particularly in repeated observations.
- CAPA
- Deviations
- Training Management
- Process Control
- Change Control
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