Method Validation (LAPTOP REQUIRED)

Method validation must be planned activity in the laboratory. The scope of the method being validated, and acceptance criteria, must be defined before method validation is initiated. Validation activities must consider the entire scope of the method and the extent of validation necessary to meet the needs of a given application, field of application, or specific customer needs. Methods must meet the specified acceptance criteria to be considered fit for intended use. From an accreditation perspective, robust method validation provides confidence that the methods employed by the laboratory are fit for the intended purpose and produce quality, reliable, and consistent analytical results. Appropriate method validation not only ensures that the laboratory can accurately and adequately perform a method, but ultimately it assures that the measurement process produces valid results. This course reviews the accreditation requirements for method validation, defines method validation and verification, and gives direction on creating a validation plan. Participants will be given practical guidance on creating and carrying out a validation plan and will have the opportunity to apply the guidance through interactive exercises. The course will include discussions on when the laboratory needs to verify a method, validate a method, validation before introducing a method into the laboratory, validation when changes to a method occur, validation of standard methods that need to be modified in the laboratory, and validation records to be retained.