Shelby N Marler
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Detailed Analysis
Mr. Marler employs a comprehensive approach, with a high level of detail orientation. He looks beyond simple compliance with procedures and focuses on the systemic issues which might lead to non-compliance. His focus areas often encompass infrastructural elements, including building design, in consideration of potential contamination and mix-ups.
Shelby N Marler is a meticulous FDA auditor with a keen focus on aseptic processes, sterility, and microbiological contamination prevention procedures. He showcases an inclination towards assessing the design of aseptic areas, environmental monitoring, and sterility tests. He also scrutinizes aspects like building design for preventing mix-ups and contamination due to space insufficiency, along with adherence to drug product labelling norm.
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