Product / Process Validation.
Validation provides confirmation that a product or process meets pre-defined specifications and is fit for purpose, i.e. meets quality, reliability, regulatory & customer requirements.
A comprehensive knowledge of validation is a necessary tool for engineers, product and process designers, quality assurance personnel, production and training staff, supervisors and managers at all levels.
An understanding of product / process validation requires an appreciation and knowledge of the benefits associated with effective validation, an understanding for when validation is appropriate versus verification, the ability to integrate risk assessment into a validation program, understanding of validation documentation, … etc..
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