Computer System Validation (CSV)
A complete, hands-on 60-hour program that builds real, job-ready CSV capability — from GAMP 5 fundamentals to modern Computer Software Assurance.
Duration
60 Hours
Fee
₹35,000 + GST
Payment
Payable in 2 parts
Mode
On-site or Online
Program Overview
This program takes participants from the fundamentals of computerised systems through to a confident, working command of risk-based validation. Built around our own structured course material and real industry case studies, it covers the full CSV lifecycle, data integrity, 21 CFR Part 11, and the modern Computer Software Assurance (CSA) approach that regulators now encourage. The fee of ₹35,000 + GST can be paid in two convenient parts.
Course Structure
- 1
Introduction to Computerised Systems & the Regulatory Landscape (GxP, FDA 21 CFR Part 11, EU Annex 11, WHO)
- 2
GAMP 5 (Second Edition) — the Risk-Based Approach & Software Categories
- 3
System Development Life Cycle (SDLC) and the V-Model
- 4
User Requirement Specification (URS), Functional & Design Specifications
- 5
Risk Assessment and Critical Thinking
- 6
Installation, Operational and Performance Qualification (IQ / OQ / PQ) & test-script writing
- 7
Requirement Traceability Matrix & Validation Summary Reports
- 8
Data Integrity and the ALCOA+ Principles
- 9
Electronic Records & Electronic Signatures — 21 CFR Part 11 in depth
- 10
Computer Software Assurance (CSA) — the modern, least-burdensome approach
- 11
Change Control, Periodic Review & maintaining the validated state
- 12
Documentation, SOPs & Audit Readiness
- 13
Case studies, hands-on exercises and final assessment
Detailed module-wise breakdown and study material provided during the program.
Who Should Attend
- QA / QC professionals
- Validation & CSV engineers
- IT and automation teams in regulated industries
- Production & engineering staff
- Regulatory affairs and compliance professionals
- Fresh graduates entering pharma / life sciences
Certification
Participants receive a certificate on successful completion of the program and assessment, recognising their CSV competency.
Enrol in the CSV Training Program
Reserve your seat or request the detailed schedule and batch dates. Fee ₹35,000 + GST, payable in two parts.
Or email training@ranucal.in
Payment Safety Notice — Beware of Fraud
The fee is per candidate and exclusive of GST. Please transfer fees only after receiving an official confirmation email from Ranucal (training@ranucal.in). Never transfer money to any individual or unofficial account. If in doubt, call us to verify before paying.