David P Van Houten
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Detailed Analysis
Mr. Van Houten takes a meticulous and comprehensive approach to inspections, focusing on detailed validation procedures, contamination control, and robust documentation. He scrutinizes the entire process from validation to documentation, ensuring strict adherence to regulatory standards.
David P Van Houten is a detail-oriented FDA investigator who places a strong emphasis on process validation, cleaning validation, contamination control, environment monitoring, sample testing, method validation, calibration management, and document management. He is particularly focused on the validation of sterilization processes, cleaning and sterilization capabilities of equipment, contamination risk control, environmental monitoring during aseptic processing, sample testing for sterility and endotoxin, validation of critical procedures, calibration procedures, and documentation for critical processes and testing activities.
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