Transcription of The Life of Test Method: Validation, Verification, and ...
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Division of Laboratory SystemsThe Life of a Test Method: Validation, Verification, and Managing QualityPresented by Rex Astles June 30, 2021 Center for Surveillance, Epidemiology, and Laboratory Services11 Excellent Laboratories, Outstanding HealthAgenda Introduction Today s Presenters New OneLab-relevant Resources Life of a Test Method: Validation, Verification, and Managing Quality Q&A Upcoming Events2 Center for Surveillance, Epidemiology, and Laboratory ServicesExcellent Laboratories, Outstanding HealthPresentersTrionaHenderson-Samuel, MDPhysician (Public Health, clinical Pathology)Training and Workforce Development Branch,DLS, Center for Surveillance, Epidemiology, and Laboratory Services (CSELS), CDCRex Astles, ScientistInformatics and Data Science Branch, DLS, Center for Surveillance, Epidemiology, and Laboratory Services (CSLES), CDC3 Center for Surveillance, Epidemiology, and Laboratory ServicesExcellent Laboratories, Outstanding HealthNew Resource: COVID-19 Viral Testing Tool Provides clinical decision support to help determine what typeof COVID-19 (caused by SARS-CoV-2) testingshould be performed.
studies and provide technical consultation • Monitor PT program performance • Manage Clinical Laboratory Improvement Advisory ... In Vitro Diagnostic Device Labeling Requirements (FDA) • The established and proprietary names of the product • The intended use or …
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