This Course is Right For You If;
- You already have a basic understand of computer system validation including GAMP®5 and 21 CFR Part 11
- Need to apply these concepts at work in a daily basis
- You have direct experience working in an FDA regulated environment
- You need an Advanced Course that goes deep into this subject
- You don’t want to waste time or money on hotel or travel fees.
This course is probably not for you, if
- You have never worked in the pharmaceutical or medical device manufacturing industry.
What is Computer System Validation (CSV)?
Computer Systems Validation (CSV) is a process used to ensure (and document) that all computer-based systems will produce information or data that meet predefined requirements. If a system meets these requirements, it can be assumed that it is consistently performing in the way it was intended.
What is a CSV Specialist?
CSV specialists plan, write, implement and review the Computer Systems Validation protocols in place within highly regulated manufacturing industries. Their work is essential to make sure that all computer-based systems are operating as intended (with documents to prove it) to meet regulatory requirements.
There is currently a high demand for trained Computer System Validation Specialists. As a result, salaries are highly competitive.
Need More Detailed Information?
What is Computer System Validation (CSV)?
What is a CSV Specialist?
What Does the Online Classroom Look Like?
We use one centralized platform where you can log into your classroom. There you can get assignments, interact with faculty and peers, reply to message boards, and more.