The essential basics of validation in chromatography
Users who have just started validating methods or begin it soon
Within this 1-day-intensive training the participants learn all about the essential basics of validation. Firstly all current validation terms and definitions are explained and their testing with the help of examples is defined. Thereby the trainer also addresses normative and regulatory requirements. Secondly the participants practice to judge single steps of a validation process relating to completeness and correct performance in teamwork.
The target of the training is to impart knowledge so that a proper performance of a validation process with the help of a validation plan is possible afterwards. Furthermore the participants are able to detect critical steps of a method and can avoid typical mistakes after the training.
- Detailed explanation of terms and definitions like “accuracy”, “limit of quantitation”, “coefficient of correlation”, coefficient of variation” etc.
- Which validation elements are tested in which manner, which extent and which time intervals?
- Regulatory requirements and individual scope
- What is often “ignored” and what is many times tested “too” extensively?
- Alternatives to the conventional validation, possible resorts in the case of time pressure
- Reasonable validation praxis dependent on the method
- New “similar” HPLC-column – have I to revalidate the method and if yes how exhaustive?
- Identification of “gaps” in validation processes – examples of praxis situations