I am a Computerized System Validation (CSV) professional with extensive experience in the pharmaceutical industry, specializing in GxP-regulated computerized systems, validation, data integrity, and regulatory compliance.

In my courses, I simplify complex CSV concepts and explain how computerized systems are assessed, validated, tested, and maintained throughout their lifecycle.

My training covers practical topics including GxP, FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+, risk assessment, the Validation V-Model, URS, Functional Specification, IQ, OQ, PQ, and other key CSV activities.

My goal is to help students, CSV professionals, validation engineers, automation engineers, QA professionals, and people entering the pharmaceutical industry develop practical knowledge that they can apply to real-world validation projects.

I focus on clear explanations, practical examples, and industry-oriented scenarios to make Computerized System Validation easier to understand.