This course is designed for people who need an introduction to computer system validation within a GMP-regulated industry.
The Code of Good Manufacturing Practice for Medicinal Products states;
“It is a requirement of GMP that manufacturers identify what validation work is needed to prove control of the critical aspects of their particular operations. Significant changes to the facilities, the equipment and the processes, which may affect the quality of the product, should be validated. A risk assessment approach should be used to determine the scope and extent of validation.”
Course Duration & Location
3-5 days, on your site or at one of our training centers.
CiPharma’s training courses can be delivered anywhere in the world. If your site is not in a city we have an office in then we ask you to cover the travel costs from our nearest office. You’ll save the costs associated with your staff travelling to be trained, so it becomes cost effective if you have several people needing training.
What you will learn
Course materials
Participants will receive a copy of the presentation(s), relevant notes and workshop materials.
A certificate of completion will be issued to participants who successfully complete the assessment.
Assessment
A written assessment is conducted at the end of the course.
Course Format
The course is a combination of lecture-style learning and active workshops with participants working in small groups on assigned tasks.
Who should attend?