Scott R Izyk
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Detailed Analysis
Scott R Izyk prioritizes attention to detail and comprehensive validation/verification procedures. He appears to have a penchant for thoroughness in CAPA systems and complaint handling processes. Additionally, he emphasizes the importance of periodic evaluations and adequate record keeping.
FDA investigator Scott R Izyk has a detailed-oriented approach and a strong focus on risk management. He tends to analyze failures in the process, and his observations indicate a particular interest in design controls, CAPA system efficiency, complaint handling processes, device corrections and removals, supplier qualification, and device history records. He is especially rigorous in making sure that verification/validation activities, investigation into root causes, and rework documentation are well accounted for.
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