The course provides an overview of the concept of qualification and validation as described in Annex 15 to Eudralex Volume 4. It covers responsibilities and terminology (qualification, validation and ...
Countless Warning Letters or FDA 483s include the following violations: “Failure to ensure, where the results of a process cannot be fully verified by subsequent inspection and test, that the process ...
What will you learn on this course? This course looks at method validation from start (initial planning) to finish (on-going tracking of performance statistics). Starting with describing the end goal ...