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✅ CSV Training (4–5 June 2026) has been delivered. Register interest for Q3 2026 →
GMP Training · 9 Modules · Certificate of Attendance

Computerised System Validation
CSV Training - Next Run: Q3 2026

Two-day hands-on training covering the complete CSV life cycle - from regulatory requirements through testing & documentation phases, case studies, and Excel sheet validation. Delivered by PHARPRO practising consultants.

🔴 Starts Tomorrow 📅 Next run: Q3 2026 - Register interest now 🕗 8:00 AM – 4:00 PM 🪑 Last Seats 🏆 Certificate of Attendance 🌐 English & Arabic
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Full Training Agenda

Two-day programme - 9 modules

The agenda is structured to progress from theory to applied practice. All times are Amman time (UTC+3).

Day 1 - Wednesday 4 June 2026
8:00 – 9:00 AM
Module 1
Introduction to Computerized System Validation (CSV)
9:00 – 10:00 AM
Module 2
CSV Regulatory Requirements
☕ Coffee Break - 10:00–10:30 AM
10:30 AM – 12:00 PM
Module 3
CSV Life Cycle
🍽 Lunch Break - 12:00–1:00 PM
1:00 – 4:00 PM
Module 4
Testing & Documentation – Concept Phase
Day 2 - Thursday 5 June 2026
8:00 – 10:00 AM
Module 5
Testing & Documentation – Project Phase
☕ Coffee Break - 10:00–10:30 AM
10:30 – 11:00 AM
Module 5 (cont.)
Testing & Documentation – Project Phase
11:00 AM – 12:00 PM
Module 6
Testing & Documentation – Operation Phase
🍽 Lunch Break - 12:00–1:00 PM
1:00 – 1:30 PM
Module 7
Testing & Documentation – Retirement Phase
1:30 – 2:00 PM
Module 8
Case Studies
2:00 – 4:00 PM
Module 9
Excel Sheet Validation
What You Will Learn

9 modules - practical CSV from first principles

Delivered by practising PHARPRO consultants who write and execute these protocols on real pharmaceutical systems.

Module 1

Introduction to CSV

  • What is CSV and why it is required
  • Overview of applicable regulations
  • FDA 21 CFR Part 11 & EU GMP Annex 11
  • ISPE GAMP 5 overview
Module 2

CSV Regulatory Requirements

  • Regulatory framework in depth
  • GAMP 5 risk categories
  • Audit trail & data integrity
  • ALCOA+ principles
Module 3

CSV Life Cycle

  • Validation Master Plan (VMP)
  • User Requirements Specification (URS)
  • Functional & Technical Specifications
  • Traceability Matrix (RTM)
Module 4

Testing & Documentation - Concept Phase

  • IQ - Installation Qualification
  • OQ - Operational Qualification
  • PQ - Performance Qualification
  • Protocol structure & acceptance criteria
Modules 5–6

Testing & Documentation - Project & Operation

  • Project phase protocol execution
  • Discrepancy management
  • Operation phase validation
  • Change control for validated systems
Module 7

Testing & Documentation - Retirement Phase

  • System retirement and decommissioning
  • Data migration & archiving
  • Validation Summary Report (VSR)
  • Residual risk documentation
Module 8

Case Studies

  • End-to-end GAMP 5 Cat. 4 system scenario
  • URS → RTM → IQ/OQ/PQ → VSR workflow
  • Data integrity case analysis
  • Inspection readiness review
Module 9

Excel Sheet Validation

  • When Excel requires validation
  • GAMP 5 classification of spreadsheets
  • Validation approach & documentation
  • Hands-on template walkthrough
Certificate

Certificate of Attendance

  • Issued to all participants
  • Covers all 9 modules
  • Accepted for GMP training records
  • Valid for regulatory training matrices
Who Should Attend

Designed for pharma validation professionals

No prior formal CSV training required - the programme starts from first principles and builds to practical application.

Validation Engineers

Who write and execute IQ/OQ/PQ protocols on pharmaceutical systems

QA Managers & Officers

Who review and approve validation documentation and SOPs

IT & Systems Managers

Who support GxP-relevant computerised systems in pharma environments

Regulatory Affairs

Professionals who prepare documentation for regulatory submission

Register

Secure your seat - training starts tomorrow

Fill in your details below. We confirm by WhatsApp/email within hours and send pre-reading materials before the session.

Q3 2026 - Register Your Interest
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Need in-house delivery for your team? Contact us to discuss →

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FAQ

CSV training questions

Validation engineers, QA/QC professionals, IT staff supporting GxP systems, regulatory affairs specialists, and anyone responsible for computerized system validation in a pharmaceutical, biotech, or medical device environment. No advanced prior CSV knowledge is required.
Introduction to CSV, Regulatory Requirements (FDA 21 CFR Part 11, EU GMP Annex 11, ISPE GAMP 5), CSV Life Cycle, Testing & Documentation (Concept Phase), Testing & Documentation (Project Phase), Testing & Documentation (Operation Phase), Testing & Documentation (Retirement Phase), Case Studies, and Excel Sheet Validation.
Yes. The programme is aligned with ISPE GAMP 5 second edition (2022), covering the updated risk-based approach, revised category definitions, and the critical thinking framework - alongside FDA 21 CFR Part 11 and EU GMP Annex 11 requirements.
Yes - a full dedicated module covers GxP spreadsheet validation: GAMP 5 classification, risk assessment, URS writing, IQ/OQ test cases including formula and macro verification, and documentation requirements for Part 11 and data integrity compliance.
Yes. PHARPRO offers bespoke private CSV training where case studies are drawn from your actual systems - LIMS, ERP, DCS, or MES. Contact us to discuss scope, dates, and format.
Yes - PHARPRO delivers CSV training in English and Arabic for pharmaceutical teams across Jordan, Saudi Arabia, UAE, Egypt, and the wider MENA region.
A PHARPRO Certificate of Attendance documenting the course title, all 9 module titles, duration, delivery date, and instructor credentials - suitable for training files, annual GMP training records, and regulatory inspection review.