Intro to Computer System Validation (CSV) EU - May 2026

Course Description:

What is computer system validation? Which systems do you need to validate? Where does validation fit into your SDLC or SALC? These are some of the questions answered in this live e-learning course.

This introductory class helps managers and team members establish a solid foundation for understanding the key concepts and skills needed to successfully deliver IT solutions in an FDA-regulated environment. This course establishes your knowledge base by focusing on the essential elements of computer system validation — all without leaving the office.

What You Get:

• An introduction to the key FDA & international regulations and guidance documents, including 21 CFR Part 11
• An overview of the computer system validation framework and deliverables, including the Validation Plan, IQ, OQ, and PQ
• The basics of inspection-ready validation testing and documentation

Who Should Attend Computer System Validation Online Training?

• System owners, IT Managers and Directors new to the FDA regulated environment
• Quality Assurance and audit professionals new to software quality
• Project Managers and team members who need to understand the validation process

Materials Provided:

Student reference materials, Certificate of Completion

Duration: 6 hours