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Computer System Validation Course

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What will I learn?

Master the essentials of Computer System Validation with our comprehensive course tailored for Operations professionals. Dive into regulatory frameworks like FDA 21 CFR Part 11 and GAMP 5, and learn to develop robust validation plans. Gain hands-on experience in executing and documenting tests, assessing risks, and designing test protocols. Enhance your skills in preparing validation reports, ensuring compliance, and addressing deviations. Elevate your expertise and ensure your systems meet industry standards efficiently.

Apoia's Unique Features

Online and lifetime access to courses
Certificate compliant with educational standards
Printable PDF summaries
Online support available at all times
Select and arrange the chapters you want to study
Set your course workload
Instant feedback on practical activities
Study anytime, no internet required

Develop skills

Strengthen the development of the practical skills listed below

Master regulatory frameworks: Navigate FDA 21 CFR Part 11 and GAMP 5.

Develop validation plans: Define scope, objectives, and timelines effectively.

Execute test protocols: Conduct and document functional, security, and performance tests.

Assess risks: Identify, document, and mitigate potential system validation risks.

Prepare validation reports: Ensure compliance and present clear, concise results.

Suggested summary

Workload: between 4 and 360 hours

Before starting, you can change 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 offers practical and relevant knowledge for your professional journey.