Good Automated Manufacturing Practice (GAMP) provides the opportunity to follow a logical and systematic approach to categorization, documentation, and risk assessment of automated systems.

During the course, the participant has acquired knowledge of:

Relevant GMP rules and guidelines for the development and verification of automation systems.
Where inspiration and guidance can be found for creating relevant documents, and which phases to go through in planning, development, and testing of the systems.
The issues at different life cycle stages and at different levels of complexity.
How risk is managed in relation to patient safety, product quality and data integrity.
How specification and verification material can be scaled according to risk.
How you, as a pharmaceutical manufacturer, can involve the subcontractor in the overall validation activities and thus avoid unnecessary duplication of work.
How you as a subcontractor live up to pharmaceutical manufacturers' expectations of good practice with subcontractors.
How software categorization can reduce the required documentation and validation activities.