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 ...

The course introduces the concept of validation to the delegates. It covers responsibilities and terminology (validation versus qualification), and looks at the requirements of equipment qualification ...

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 ...