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New CPQA Bioanalytical Method Validation Tutorial

New CPQA Bioanalytical Method Validation Tutorial

March 01, 2016

The Clinical Pharmacology Quality Assurance and Quality Control Program (CPQA) is pleased to announce the availability of a new online tutorial, Bioanalytical Method Validation Overview. This online tutorial illustrates the many steps required to validate a chromatographic method for analyzing analyte-specific concentrations in patient samples.

The course is designed to provide the learner with information necessary to comprehend, design, perform, analyze, and evaluate a bioanalytical method validation. The validation procedures and regulations are applied to chromatographic methods used to quantitate drugs, metabolites, or other small molecules of interest. Objectives are provided prior to each of the seven modules, which include validation overview, reagents, calibration, quality control and specificity, accuracy and precision, selectivity, and stability.

To earn a certificate of completion for this course, learners must complete the pre-test, review all the material presented in each module, complete each module’s quiz, and complete the post-test. Each quiz score must be 80 percent or higher to count towards the certificate of completion. Learners also have the option to review only the course material and not take the quizzes. Just follow the on-screen instructions to skip the link to take the quiz in the tutorial navigation on the DAIDS Learning Management System (LMS).

Access the Clinical Pharmacology Tutorial on the DAIDS Learning Management System. If you do not already have an account, you must request one using the form provided on the website.

The tutorial takes approximately two hours to complete. A certificate is issued upon completion.

Please contact with any questions.