This Method Validation training in drug development process will provide guidance in setting appropriate specifications, determining if the assay is validatable, and monitoring progress during the validation.
This webinar will address frequently observed issues and problems with method validations. Validated methods are required for Phase III of the drug development process. Moving methods from the development phase to the validated phase ready for sample analysis does not always occur without unforeseen issues arising. Differences in laboratories and analysts, as well as instrumentation can contribute to delays in validating methods.
Areas Covered in the Seminar:
- Importance of defining the method and trending necessary information. Importance of setting appropriate specifications.
- Designing appropriate assays.
- Establishing correct specifications.
- Identifying an appropriate reference standard.
- Building on the foundation of a good qualification.
- Creating effective templates for validation studies.