Computer System Validation Course
What will I learn?
Master the fundamentals of Computer System Validation with our detailed course designed for Operations professionals. Deep dive into regulatory guidelines such as FDA 21 CFR Part 11 and GAMP 5, and learn to create strong validation plans. Get practical experience in performing and recording tests, evaluating risks, and designing test protocols. Improve your abilities in writing validation reports, ensuring regulatory compliance, and handling deviations. Enhance your expertise and ensure your systems efficiently meet industry standards.
Apoia's Advantages
Develop skills
Enhance the development of the practical skills mentioned below
Master regulatory guidelines: Navigate FDA 21 CFR Part 11 and GAMP 5.
Develop validation plans: Clearly define scope, objectives, and timelines.
Execute test protocols: Perform and document functional, security, and performance tests.
Assess risks: Identify, record, and mitigate potential system validation risks.
Prepare validation reports: Ensure regulatory compliance and present clear, concise findings.
Suggested summary
Workload: between 4 and 360 hours
Before starting, you can modify the chapters and the workload.
- Choose which chapter to start with
- Add or remove chapters
- Increase or decrease the course workload
Examples of chapters you can add
You will be able to generate more chapters like the examples below
This is a free course, focused on personal and professional development. It is not equivalent to a technical, undergraduate, or postgraduate course, but provides practical and relevant knowledge for your professional journey.