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        T134 Registration Fee (non-member) $45.00
        T134 Registration Fee (member) $25.00
        T134 Verification/Validation of Molecular Assays/Platforms


        Date: February 12, 2013; 2:00 p.m. (EST)
        Speaker: Michael J. Loeffelholz, Ph.D.

        Description: Clinical laboratories are required to verify or establish the performance characteristics of new tests, including molecular methods, as defined in the Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) checklists. However, much of the details of this process are left to the laboratory.  The objective of this program is to provide practical guidance on the verification of molecular assays and platforms.

        Intended Audience: The course is open to anyone! However, since it is a practical course, laboratory personnel (e.g., medical technologists, supervisors, and directors) with a minimum of a bachelors-degree and familiarity with clinical microbiology would benefit the most. Limited to U.S. and Canadian residents.

        Objectives: Following this session, the participants should be able to:

        • List components of the verification/validation process.
        • Describe the process of verifying an FDA-cleared or approved molecular assay.
        • Describe the process of verifying a modified or laboratory-developed molecular assay.

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