Product and Process Validation …
What is the necessity for product and process Validation?
Validation provides confirmation that a product or process meets pre-defined specifications and is fit for purpose, i.e. meets quality, reliability & customer requirements.
Who needs to understand and be able to effectively implement Validation?
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 or Process Validation requires an appreciation and knowledge of …
The benefits of performing validation.
An understanding for when validation is appropriate versus verification.
The ability to integrate risk assessment into a validation program.
An ability to perform a validation gap analysis.
Knowledge of the requirements of the Validation Master Plan.
An ability to perform validation during a product and process design phase.
Understanding of the approaches to software validation.
Understanding of validation documentation.
Capabilities in terms of equipment, component, material and facility validation.
Capability to implement a revalidation program.
Ability to complete validation protocol reporting.
Implementation of an auditing for validation compliance process.