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 verification), and looks at the requirements of equipment qualification (IQ, OQ and PQ), process and cleaning validation, analytical method validation. The need for effective change management and lifecycle management will be discussed. The course also examines the documentation and project management aspects of validation studies.

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