This course covers the essential principles contained in GAMP 5: A Risk Based Approach to Compliant GxP Computer Systems Validation. This GAMP course is designed for professionals seeking training in the requirements of GAMP 5, for example;
- Quality Assurance personnel
- IT personnel
- Engineering personnel
“There are major business benefits in having a defined process that delivers systems that are fit for intended use, on time, and within budget. Systems that are well defined and specified are easier to support and maintain, resulting in less downtime and lower maintenance costs…”
ISPE, GAMP 5, A Risk-Based Approach to Compliant GxP Computerized Systems”
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.
Completely understand the key concepts of GAMP 5
Have a through understanding of the V model and its application to GxP computer systems
Be able use the GAMP 5 Risk Based approach to reduce validation costs
Know how to write and structure a User Requirements Specification, Functional Specification and Design Specification using the Risk-Based approach
Know what a design review / qualification is and when it is used
Know how the validation ‘V’ model applies to GxP computerized systems
Be able to plan scalable validation processes according to patient safety, product quality and data integrity priorities
Know how to direct computerized validation projects
Understand the major life cycle phases of computerized systems, from concept to retirement
Understand software categorization and the Validation efforts required for various computerized systems
Understand the decision process – selecting off the shelf, customized or totally novel computerized systems
Understand computerized system validation from a regulator’s perspective
Know how to do code reviews
Understand Electronic Records Electronic Signatures (ERES) and CFR Part 11 compliance
Be able to identify key validation deliverables
Know how to leverage supplier involvement to reduce duplication
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.
Quality Assurance personnel
Operations or Manufacturing personnel
IT personnel
