The objectives of this Education Course are
- to offer practical solutions for determining the validation characteristics
- to learn how to deal with measurement uncertainty and to understand its impact on analytical methods validation
- to discuss the scope of validation necessary to obtain approval by the Registration Authorities (EMA, FDA, MHRA, etc.)
- to become familiar with the statistical parameters to be applied
- to understand the qualification of laboratory equipment as a precondition of reliable analytical testing
- to outline the documentation (SOPs, Validation Protocols and Reports, etc.) which you should have in your lab.
In order to improve the understanding and practical application of the contents of the lectures, workshops will be part of the training course.