This module is designed to introduce users of various pharmaceutical industry equipment to the different stages of equipment qualification such as design, installation, performance and general operations.
|Who is it for||
Employees in production, engineering, quality control and quality assurance, either directly operating or maintaining equipment and utilities should complete this module.
|Why it matters||
Equipment used in production, especially the ones that come in direct contact with the drug product can affect product quality and patient safety. Qualification ensures that equipment is fit-for-intended use throughout its lifecycle from concept to retirement. It provides assurance that the systems that can impact product quality have been properly designed, installed, and tested according to pre-determined acceptance criteria. Frequent review and appropriate management of facilities, equipment, and utilities of an organization ensures the delivery of safe and high-quality products.