Computer System Validation Training Course Overview
This one day computer system validation training course is designed for validation practitioners who need an introduction and practical understanding of how to select, deploy and validate computerised (IT) systems validation within a GMP-regulated industry.
As the EU and PIC/S 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
One day, on your site or at an offsite location.
The computer system validation training course can be delivered anywhere in the world, we will ask you to cover reasonable travel costs, with this you could save the costs associated with your staff travelling to a external venue to be trained, so it becomes cost effective if you have several people needing training.
Our 2018 pricing is A$350 per person or A$3500 per day plus GST for up to 15 participants. This does not include travel costs.
*Smart device and WiFi is needed for all attendees.
Contact us for a quote if you need more that 10 trainees to be trained.
What you will learn
Upon completion of this course participants will;
- Understand the importance of validation and why and how the information is collected and used
- Have an understanding of the V model and how it is used
- Know what Validation Master Plans (VMP), User Requirements Specifications, Functional Specifications and Design Specifications are and how and when to use them.
- Know what Design review / Design Qualification are and when they should be used in a project
- Know the steps involved in Installation Qualification, Operational Qualification and Performance Qualification
- Know what a Validation Summary Report is and when it should be used
- Be able to perform basic validation testing
- Have a rudimentary understanding of risk based validation
- Understand how to adopt sensible validation practices
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.
A written assessment is conducted at the end of the course.
The course is a combination of lecture-style learning and active workshops with participants working in small groups on assigned tasks.
Who should attend?
- IT professionals
- CSV engineers
- Quality Assurance personnnel
- Quality Control personnel
- Operations or Manufacturing personnel
- Engineering personnel
If you would like a quote or would need to ask questions, please contact us.