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CSV Training · Upcoming Event

Computerised System Validation Training — 5 & 6 August 2026: 8 Modules, Full CSV Lifecycle, Inspection-Ready

7 min read By Mohammad Awawdeh, PHARPRO
5 & 6 August 2026  ·  2-day intensive  ·  Online & In-Person  ·  Certificate of Completion
📅
Dates
5 & 6 Aug 2026
Duration
16 Training Hours
📋
Modules
8 Core Modules
💻
Mode
Online & In-Person
🏅
Certificate
Upon Completion
👥
Seats
Max 20

CSV documentation failures remain the #1 trigger for FDA 483 observations and EU GMP Annex 11 non-conformances across the MENA region. Regulatory inspectors know what a gap-filled validation package looks like — and so does your competition. The question is: does your team?

PHARPRO's Computerised System Validation Intensive returns on 5 & 6 August 2026. Two full days, eight precision-targeted modules covering the complete CSV lifecycle from Concept through Retirement, and a practical documentation framework your team can apply from day one back at the office. Seats are limited to 20 participants. No exceptions.

This cohort fills weeks before the date. If your team needs this training before Q4 audit season, register today — not the week before. Reserve your seat →

Why CSV Training Is Non-Negotiable in 2026

What happens when CSV documentation fails inspection
⚠️FDA 483 observations citing missing IQ/OQ/PQ protocols — immediate remediation required
⚠️EU GMP Annex 11 non-conformances leading to product release holds
⚠️GAMP 5 misapplication: wrong risk category = wrong validation approach = wasted effort
⚠️Data integrity gaps: missing audit trails, uncontrolled spreadsheets, no e-signature policy

Two days of training at this level is not an expense — it's the difference between a clean inspection report and 18 months of remediation. We've seen both outcomes with pharma companies across Jordan, UAE, KSA, and Egypt. The ones who invest in structured CSV training rarely end up in the second category.

8 Modules. The Full CSV Lifecycle — Concept to Retirement.

01Introduction to CSV — GxP Regulations, Validation vs. Qualification, What is CSV, GAMP 5 Overview
02CSV Regulatory Requirements — EU GMP Annex 11, 21 CFR Part 11, ALCOA++ Data Integrity, WHO TRS 996 Annex 5
03CSV Life Cycle — Concept, Project, Operation & Retirement Phases
04Testing & Documentation: Concept Phase — URS, Risk Assessment, SIA, Categorisation, V-Model & Validation Plan
05Testing & Documentation: Project Phase — IQ / OQ / PQ, Data Migration, Traceability Matrix & VSR
06Testing & Documentation: Operation Phase — SOPs, Audit Trail Review, User Access, CAPA & Change Management
07Testing & Documentation: Retirement Phase — Change Control, Risk Assessment, Data Management & Archiving
08Case Studies — Track & Trace, AI Systems, BMS Software, Pharma 4.0 Real-World Examples

Templates included: Participants receive a full CSV documentation pack — URS template, risk assessment matrix, IQ/OQ/PQ protocol shells, and change control form — ready to adapt for your systems.

Two-Day Training Agenda

TimeModule / Activity
Day 1 — Wednesday, 5 August 2026
09:00 – 10:00Module 1: Introduction to CSV — GxP Regulations, Validation vs. Qualification, What is CSV, GAMP 5 Overview
10:00 – 11:00Module 2: CSV Regulatory Requirements — EU GMP Annex 11, 21 CFR Part 11, ALCOA++ Data Integrity, WHO TRS 996 Annex 5
11:00 – 12:00☕ Coffee Break
12:00 – 14:00Module 3: CSV Life Cycle — Introduction, Concept Phase, Project Phase, Operation Phase & Retirement Phase
14:00 – 15:00🍽 Lunch Break
15:00 – 17:00Module 4: Testing & Documentation – Concept Phase — URS, Initial Risk Assessment, System Impact Assessment, Categorisation, Functional Risk Assessment, V-Model & Validation Plan
Day 2 — Thursday, 6 August 2026
09:00 – 11:00Module 5: Testing & Documentation – Project Phase — IQ / OQ / PQ, Data Migration, Risk Residual Reports, Validation Plan Review, Traceability Matrix & Validation Summary Report (VSR)
11:00 – 12:00☕ Coffee Break
12:00 – 14:00Module 6: Testing & Documentation – Operation Phase — Disaster Recovery, Business Continuity, Backup & Restore, User Access Management, Audit Trail Review, Incident Management, CAPA & Change Management
14:00 – 15:00🍽 Lunch Break
15:00 – 15:30Module 7: Testing & Documentation – Retirement Phase — Change Control, Risk Assessment, Data Management & Data Archiving
15:30 – 17:00Module 8: Case Studies — Track & Trace, AI Systems, BMS Software, Pharma 4.0 Real-World Examples & Q&A

Seats filling fast — limited to 20 participants. The August cohort is your last CSV intensive before Q4 audit season.

Reserve My Seat →

This Training Is For You If…

⚙️Validation Engineers
🔬QA Officers & Managers
💻IT Managers (GxP Systems)
📋Regulatory Affairs Teams
🏭Project Managers (System Implementations)
🎓Pharma Graduates Entering Validation

No prior CSV experience required. The course is built to work for both new entrants and experienced professionals who want to refresh and formalise their validation approach.

Why PHARPRO — Not a Generic Online Course

  • Practitioner-led — instructors who have written IQ/OQ/PQ protocols for live pharma implementations across MENA
  • Case studies from real inspections — FDA 483 observations, EU Annex 11 findings, and how they were resolved
  • Template-first approach — you leave with ready-to-use documentation, not just slides
  • Inspector's perspective — every module taught through the lens of what auditors actually check
  • Certificate of Completion — 16 CPD hours, suitable for GMP training records
  • Interactive Q&A — bring your real system challenges and get expert guidance live

PHARPRO has delivered pharmaceutical compliance and validation consulting since 2014. Our CSV training is not theoretical — it's built on the same frameworks we apply in real client engagements across Jordan, UAE, KSA, Egypt, and beyond.

تدريب CSV من PHARPRO — بالعربية

تدريب التحقق من الأنظمة الحاسوبية (CSV) من PHARPRO — يومان مكثفان، 8 وحدات، 16 ساعة تدريبية تغطي دورة حياة CSV الكاملة: من مرحلة المفهوم حتى مرحلة الاستبعاد. يُقدَّم بالعربية والإنجليزية، أونلاين ووجاهياً في عمّان. يشمل التدريب: GAMP 5، كتابة بروتوكولات IQ/OQ/PQ، نزاهة البيانات (ALCOA++)، EU GMP Annex 11، و21 CFR Part 11، فضلاً عن دراسات حالة حقيقية. شهادة إتمام معتمدة. للتسجيل أو الاستفسار: واتساب +962 79 856 5807 أو البريد [email protected]

Common Questions

How do I register?

Complete the registration form below, email [email protected], or WhatsApp +962 79 856 5807. State your name, company, and preferred format (online or in-person). Confirmation is sent within 24 hours.

Is this available online?

Yes — both online (live instructor-led) and in-person in Amman are available. Online participants receive the same materials and certificate. Stable internet and a device with audio are all you need.

Can I register a group?

Yes. Group registrations of 3 or more participants are welcome. Corporate in-house delivery can also be arranged for larger teams. Contact us to discuss pricing and scheduling.

Will I receive a certificate?

Yes. All participants receive a Certificate of Completion issued by PHARPRO Consultation Company, confirming 16 hours of CSV training — suitable for your GMP training records file.

CSV Training 2026 GAMP 5 IQ OQ PQ FDA 21 CFR Part 11 EU GMP Annex 11 Data Integrity Pharma Training MENA Region

Reserve Your Seat — CSV Training, 5 & 6 August 2026

Limited to 20 participants. Complete the form and we will confirm within 24 hours.

Or WhatsApp us directly: +962 79 856 5807

Don't Miss This Cohort — Register Before Seats Close

CSV Training — 5 & 6 August 2026  ·  16 hours  ·  8 modules  ·  Templates & Certificate  ·  Online & In-Person

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