This lecture will provide attendees with the knowledge and skills to bring on new clinical laboratory tests in clinical chemistry and molecular diagnostics. The lecture will provide a general overview of the CLIA and CAP regulatory requirements for the implementation of new tests, including conducting test validation, discussing the analytical measurement range (as appropriate for quantitative assays), cut offs for qualitative tests and carry over identification. The lecture will discuss some examples from the areas of clinical chemistry and molecular diagnostics which are related the general principles of validation.