The new ICH and USP guidelines have introduced some changes in the validation of analytical methods. Some of the changes are due to the inclusion of methods that were previously undefined such as methods for determining activity, widely used in the evaluation of biological drugs. Another part is due to the introduction of QbD solutions into the area of analytical method lifecycle management and regulation of the analytical method development process.
During the training, trainees will learn what guidelines affect the validation process, what are validation tests and how they should be performed, how to plan validation studies and what acceptance criteria should be adopted.
The training will be conducted in a workshop format, in which teamwork will be interspersed with the presentation of material and discussion.
Laboratory personnel developing analytical methods, personnel building analytical strategy, control and quality assurance personnel.
Scope of the training
- Regulatory environment
- Types of analytical methods
- Validation tests
- Scope of validation
- Validation protocol
- Conducting validation tests
- Dealing with deviations
- LEAN report – how to avoid unnecessary “paperwork”