Pharmaceutical validation engineers and QA teams across the MENA region consistently tell us the same thing: CSV documentation is one of their biggest compliance headaches - not because the science is unclear, but because the application of GAMP 5, the structure of qualification protocols, and the documentation of data integrity controls are rarely taught in a practical, hands-on format.
That is exactly why PHARPRO runs its Computerised System Validation Intensive - a two-day programme that takes participants from first principles through to a complete, inspection-ready documentation approach. The next cohort runs 4–5 June 2026, and seats are limited.
Seats are limited to 20 participants. This training typically fills 2–3 weeks before the date. If your team needs this, register early - not the week before.
Why CSV Training Matters More in 2026
Regulatory scrutiny of computerised systems has increased significantly since the MHRA and FDA updated their data integrity guidance. EU GMP Annex 11 inspections are no longer primarily about whether you have validation documentation - they're about whether your validation evidence demonstrates genuine understanding of risk, control, and lifecycle management.
Common inspection findings from the past 18 months include:
- IQ/OQ/PQ protocols that were executed but lack proper acceptance criteria rationale
- Risk assessments that classify systems as GAMP 5 Category 4 without documented justification
- Audit trail reviews that were performed annually rather than continuously, with no SOP backing
- Change control records for validated systems that were not reviewed for validation impact
- User Requirements Specifications written after system installation, with no URS-to-test traceability
These are not exotic findings - they appear repeatedly across mid-size pharmaceutical manufacturers, contract research organisations, and hospital pharmacies. The underlying cause is almost always the same: the team knows what to produce but not how to think through it properly.
What the 2-Day Training Covers
The PHARPRO CSV Intensive is delivered by our practicing validation consultants - people who write and execute these protocols on actual pharmaceutical systems. The agenda is structured to move participants from regulatory theory to applied documentation practice.
| Module | Activity | Time |
|---|---|---|
| Day 1 - Wednesday 4 June 2026 | ||
| Module 1 | Introduction to Computerized System Validation (CSV) | 8:00 – 9:00 AM |
| Module 2 | CSV Regulatory Requirements | 9:00 – 10:00 AM |
| ☕ Coffee Break | 10:00 – 10:30 AM | |
| Module 3 | CSV Life Cycle | 10:30 AM – 12:00 PM |
| 🍽 Lunch Break | 12:00 – 1:00 PM | |
| Module 4 | Testing & Documentation – Concept Phase | 1:00 – 4:00 PM |
| Day 2 - Thursday 5 June 2026 | ||
| Module 5 | Testing & Documentation – Project Phase | 8:00 – 10:00 AM |
| ☕ Coffee Break | 10:00 – 10:30 AM | |
| Module 5 | Testing & Documentation – Project Phase (cont.) | 10:30 – 11:00 AM |
| Module 6 | Testing & Documentation – Operation Phase | 11:00 AM – 12:00 PM |
| 🍽 Lunch Break | 12:00 – 1:00 PM | |
| Module 7 | Testing & Documentation – Retirement Phase | 1:00 – 1:30 PM |
| Module 8 | Case Studies | 1:30 – 2:00 PM |
| Module 9 | Excel Sheet Validation | 2:00 – 4:00 PM |
Who Should Attend
This training is designed for professionals with direct responsibility for validation or compliance in regulated pharmaceutical environments:
- Validation engineers who write and execute IQ/OQ/PQ protocols
- QA managers and officers who review and approve validation documentation
- IT and systems managers who support GxP-relevant computerised systems
- Regulatory affairs professionals who prepare documentation for submission
- Project managers overseeing system implementations in regulated environments
Participants do not need prior formal training in CSV - the programme starts from first principles and builds to advanced application. Experienced validation engineers will benefit most from the case study sessions and the structured approach to risk documentation.
Practical Detail: How the Training Is Structured
Unlike lecture-based compliance training, PHARPRO's intensive uses real documentation examples throughout. Participants work with actual protocol templates, risk assessment worksheets, and case study materials. By the end of Day 2, each participant will have:
- A structured URS template adapted to their system types
- An IQ/OQ/PQ framework ready to apply to their next validation project
- A GAMP 5 risk classification methodology they can defend in an audit
- A data integrity checklist aligned to Annex 11 requirements
- Understanding of how to use PHARPRO DVS to generate these documents in a fraction of the time
PHARPRO DVS participants: If your organisation uses PHARPRO DVS, our AI validation lifecycle platform, Day 2 includes a hands-on session showing how to apply the training frameworks directly within the platform - from AI-assisted URS drafting through to automated RTM generation.
What Past Participants Have Said
Participants from our previous cohorts have included teams from Dar Al Dawa, Al Hayat Pharmaceuticals, Axantia Group, and several clinical research organisations across Jordan, Saudi Arabia, and the UAE. Feedback consistently highlights two things: the practical, non-generic nature of the material, and the applicability to their specific regulatory environment.
"The case study on Day 2 was the most useful part - seeing how the documents connect from URS through to VSR in a single scenario made the whole framework click."
"Our QA team has been writing IQ/OQ/PQ protocols for years. This training gave us a framework for the risk rationale that we'd never had documented internally. Directly applicable to our next FDA inspection."
Upcoming PHARPRO Training Calendar
The CSV Intensive is part of PHARPRO's 2026 training calendar for pharmaceutical teams in MENA:
- 4–5 June 2026: Computerised System Validation (CSV) Intensive ← this programme
- 10–11 June 2026: Compressed Air Testing & Qualification
- 17–18 June 2026: Cleaning Validation - MACO, Acceptance Criteria & Protocol Writing
Teams that need both CSV and cleaning validation coverage can register for both - PHARPRO offers group pricing for organisations sending three or more participants to the same programme.
Register - Secure Your Seat Now
Training starts tomorrow - 4 June 2026. Fill in the form below to reserve your seat. We confirm within hours. WhatsApp registration also available at +962 79 856 5807.
If your team requires an in-house delivery of this programme - customised to your systems, your QMS, and your regulatory context - contact us to discuss dates and scope.