Computerised System Validation
CSV Training - 16–17 September 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.
Two-day programme - 9 modules
The agenda is structured to progress from theory to applied practice. All times are Amman time (UTC+3).
Introduction to Computerized System Validation (CSV)
CSV Regulatory Requirements
CSV Life Cycle
Testing & Documentation – Concept Phase
Testing & Documentation – Project Phase
Testing & Documentation – Project Phase
Testing & Documentation – Operation Phase
Testing & Documentation – Retirement Phase
Case Studies
Excel Sheet Validation
9 modules - practical CSV from first principles
Delivered by PHARPRO founder Mohammad Awawdeh, who writes and executes validation protocols for pharmaceutical systems.
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
CSV Regulatory Requirements
- Regulatory framework in depth
- GAMP 5 risk categories
- Audit trail & data integrity
- ALCOA+ principles
CSV Life Cycle
- Validation Master Plan (VMP)
- User Requirements Specification (URS)
- Functional & Technical Specifications
- Traceability Matrix (RTM)
Testing & Documentation - Concept Phase
- IQ - Installation Qualification
- OQ - Operational Qualification
- PQ - Performance Qualification
- Protocol structure & acceptance criteria
Testing & Documentation - Project & Operation
- Project phase protocol execution
- Discrepancy management
- Operation phase validation
- Change control for validated systems
Testing & Documentation - Retirement Phase
- System retirement and decommissioning
- Data migration & archiving
- Validation Summary Report (VSR)
- Residual risk documentation
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
Excel Sheet Validation
- When Excel requires validation
- GAMP 5 classification of spreadsheets
- Validation approach & documentation
- Hands-on template walkthrough
Certificate of Attendance
- Issued to all participants
- Covers all 9 modules
- Accepted for GMP training records
- Valid for regulatory training matrices
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 for 16–17 September 2026
Fill in your details below. We confirm by WhatsApp or email within one business day and send joining information before the session.
Need in-house delivery for your team? Contact us to discuss →
CSV training questions
More questions
When does the CSV training start?
Public CSV training runs on a recurring schedule; check the current dates above or contact PHARPRO for the next available session. Participants may attend online or in person, and private delivery for company teams can be arranged separately.
Is the CSV training available in Arabic?
Yes - PHARPRO delivers CSV training in both English and Arabic to serve pharmaceutical teams across Jordan, Saudi Arabia, UAE, Egypt, and the wider MENA region.
What modules does the CSV training cover?
9 modules: 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.
Who should attend PHARPRO CSV training?
This course is designed for 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 knowledge of CSV is required.
What certificate do participants receive for the CSV training?
All participants receive a PHARPRO Certificate of Attendance documenting the course title, content modules, duration, delivery date, and instructor credentials. The certificate is suitable for annual training files and provides verifiable evidence of GMP training for FDA, EU GMP, WHO, and JFDA inspection purposes.
Does the CSV training cover GAMP 5 second edition?
Yes. The PHARPRO CSV training is aligned with ISPE GAMP 5 second edition (2022), covering the updated risk-based approach, category definitions, and critical thinking framework - alongside FDA 21 CFR Part 11 and EU GMP Annex 11 requirements.
Can the CSV training be customised for our organisation's systems?
Yes. PHARPRO offers bespoke private CSV training where the case studies and worked examples are drawn from your organisation's specific computerized systems - such as your LIMS, ERP, DCS, or MES. Contact us to discuss scope, dates, and format for a private cohort.
Is Excel spreadsheet validation covered in the CSV training?
Yes - Excel sheet validation is a dedicated module within the 9-module programme. It covers GAMP 5 classification of spreadsheets, risk assessment, User Requirements Specification, IQ/OQ test cases (including formula and macro verification), and documentation requirements for Part 11 and data integrity compliance.