FREE Learning Path
🎯 Computer System Validation (CSV) Expert
FREE Learning Path – Complete Checklist
Your 16-Week Journey to Becoming CSV Job-Ready
Start Date: __________ | Target Completion: __________
📚 Essential Free Resources Bookmark
FDA.gov – 21 CFR Part 11 regulations
EudraLex.europa.eu – EU Annex 11
Udemy.com – Free CSV courses
YouTube – Search “CSV pharmaceutical tutorials”
LearnAboutGMP.com – Articles and forums
ValidationCenter.com – Free webinars
LinkedIn Learning – 1-month free trial
SlideShare.net – Free presentations
📖 PHASE 1: FOUNDATION (Weeks 1-4)
Goal: Understand regulatory requirements, CSV basics, and GAMP 5 framework
Week 1: Regulatory Basics – 21 CFR Part 11
Day 1-2: Read FDA 21 CFR Part 11
Go to FDA.gov and search “21 CFR Part 11”
Read complete regulation (2-3 hours)
Create notes document “21 CFR Part 11 Key Points”
Define: Electronic records
Define: Electronic signatures
List all Part 11 requirements (minimum 10)
Note key terms: Audit trail, validation, controls
Day 3-4: YouTube Education
Search: “21 CFR Part 11 explained”
Watch at least 30 min of educational content
Search: “Electronic records and signatures”
Take detailed notes on audit trails
Take notes on data security requirements
Write 3 real-world examples where Part 11 applies
Day 5-7: EU Annex 11
Download EU Annex 11 PDF from EudraLex website
Read complete document (highlight important sections)
Create comparison table: Part 11 vs Annex 11
List 5 key differences between US and EU
Identify overlapping requirements
✓ Week 1 Checkpoint:
Can explain Part 11 in 3 minutes
Understand what needs validation
Have organized, detailed notes
Week 2: Introduction to CSV
Day 1-2: CSV Fundamentals
YouTube: “What is CSV in pharmaceutical industry”
YouTube: “Computer System Validation introduction”
YouTube: “Why CSV is important”
Write definition of CSV in your own words
List 5 types of systems requiring validation
Understand difference: Validation vs Qualification
Day 3-5: FREE Udemy Course
Enroll: “Computer System Validation and QMS”
Complete Module 1: Introduction to CSV
Complete Module 2: Regulatory requirements
Take all module quizzes (score 80%+)
Create flashcards for key terms (minimum 20)
Day 6-7: Industry Resources
Create free account at LearnAboutGMP.com
Read 3 articles on CSV basics
Join their discussion forum
Bookmark 5 useful resources
Post one question in forum for engagement
✓ Week 2 Checkpoint:
Can explain why pharma systems need validation
Know difference: validation vs qualification
Have started building vocabulary list (20+ terms)
Week 3: GAMP 5 Fundamentals
Day 1-2: Udemy GAMP 5
Complete all GAMP 5 modules in Udemy course
Understand all 5 software categories
Take detailed notes on risk-based approach
Complete all course quizzes successfully
Get certificate of completion
Day 3-4: GAMP 5 Deep Dive
YouTube: “GAMP 5 overview and categories”
YouTube: “Risk-based validation approach”
YouTube: “GAMP 5 vs GAMP 4 differences”
Create chart: Categories 1-5 with 3 examples each
Understand which category needs most validation
Day 5-7: Study Materials
SlideShare: Search “GAMP 5 pharmaceutical”
Download 5 best presentations
Study each presentation thoroughly
Create your own 1-page GAMP 5 summary
Draw complete GAMP 5 V-model diagram
✓ Week 3 Checkpoint:
Can categorize any software system (1-5)
Can draw and explain V-model
Understand risk-based validation approach
Week 4: Quality Management Basics
Day 1-3: LinkedIn Learning
Sign up for 1-month FREE trial
⚠️ SET CALENDAR REMINDER to cancel in 28 days
Take: “Quality Management Fundamentals”
Take: “Introduction to Project Documentation”
Complete minimum 2 hours of courses
Day 4-5: Quality Concepts
YouTube: “GMP in pharmaceutical industry”
YouTube: “Quality Risk Management ICH Q9”
YouTube: “Deviation management pharmaceutical”
List 5 core quality principles
Understand GMP vs GLP vs GCP
Day 6-7: Review & Consolidate
Review ALL Week 1-4 notes
Create mind map of everything learned
Write 2-page summary of CSV basics
Test yourself: Explain CSV to someone
Identify any knowledge gaps
✓ Phase 1 Complete – Major Checkpoint:
Understand regulatory requirements (Part 11, Annex 11)
Know what CSV is and why it matters
Understand GAMP 5 framework completely
Have organized notes and resources
Ready to move to Phase 2
🔧 PHASE 2: CORE KNOWLEDGE (Weeks 5-8)
Goal: Master validation lifecycle, IQ/OQ/PQ, and data integrity principles
Week 5: Validation Lifecycle Part 1
Day 1-2: System Development Lifecycle
YouTube: “SDLC in pharmaceutical validation”
YouTube: “V-model software development”
Draw complete V-model with all phases labeled
Understand: Requirements → Design → Build → Test
Learn how testing links to requirements
Day 3-4: User Requirements Specification (URS)
YouTube: “How to write URS pharmaceutical”
Read 2 articles on URS writing techniques
Google: Download free URS template
Study template structure and sections
List 10 elements that must be in a URS
Understand: Functional vs Non-functional requirements
Day 5-7: Functional Specifications
YouTube: “Functional specifications vs URS”
Understand: User needs vs System functions
Read 2 articles on functional spec writing
Create comparison table: URS vs Functional Spec
Write 5 sample functional requirements
✓ Week 5 Checkpoint:
Can draw and explain complete V-model
Know what goes in a URS
Can differentiate URS from Functional Spec
Week 6: Validation Lifecycle Part 2 – IQ/OQ/PQ
Day 1-2: Installation Qualification (IQ)
YouTube: “IQ OQ PQ explained pharmaceutical”
YouTube: “Installation Qualification protocol”
Understand: What is checked during IQ
List 10 typical IQ test items
Find and study an IQ protocol example online
Understand hardware vs software IQ
Day 3-4: Operational Qualification (OQ)
YouTube: “Operational Qualification pharmaceutical”
Understand: Testing at operating ranges
List 10 typical OQ test scenarios
Understand: Challenge tests and worst-case scenarios
Learn about boundary testing
Day 5-7: Performance Qualification (PQ)
YouTube: “Performance Qualification examples”
Understand: Real-world production testing
Study PQ vs OQ key differences
Create comprehensive table: IQ vs OQ vs PQ
Write down when each qualification is used
Understand concurrent vs prospective validation
✓ Week 6 Checkpoint:
Can clearly explain IQ, OQ, PQ to anyone
Know what gets tested in each phase
Can identify which qualification a test belongs to
Week 7: Documentation & Traceability
Day 1-2: Validation Protocols
YouTube: “How to write validation protocol”
Study protocol structure: Purpose, Scope, Responsibilities
Understand: Test scripts vs protocols difference
Download 2-3 protocol templates from internet
Identify common sections in all protocols
Learn about acceptance criteria writing
Day 3-4: Traceability Matrix
YouTube: “Traceability matrix validation”
Understand: Requirements → Design → Tests linkage
Create sample traceability matrix in Excel
Practice: Link 5 requirements to test cases
Ensure 100% bidirectional traceability
Day 5-7: Documentation Skills
LinkedIn Learning: “Technical Writing” course
LinkedIn Learning: “Project Documentation”
Practice writing clear, concise procedures
Review professional documentation standards
Learn about version control in documentation
✓ Week 7 Checkpoint:
Can structure a validation protocol properly
Understand complete traceability concept
Have practiced writing documentation
Week 8: Data Integrity – ALCOA+
Day 1-2: ALCOA+ Principles
YouTube: “ALCOA principles pharmaceutical”
YouTube: “Data integrity FDA guidance”
Memorize: Attributable, Legible, Contemporaneous, Original, Accurate
Add +: Complete, Consistent, Enduring, Available
Write practical examples for each principle
Day 3-4: FREE Webinar
Visit: ValidationCenter.com
Register: “Fundamentals of 21 CFR Part 11” webinar
Attend live session OR watch recording
Take detailed notes (minimum 2 pages)
Write down 5 key takeaways
Ask questions during Q&A if live
Day 5-7: FDA Guidance & Warning Letters
Download: FDA Data Integrity Guidance PDF
Read complete document (20-30 pages)
Highlight all critical requirements
Search: Read 3 FDA warning letters on data integrity
List 10 common data integrity violations
Understand consequences of non-compliance
✓ Phase 2 Complete – Major Checkpoint:
Understand complete validation lifecycle
Know IQ/OQ/PQ thoroughly
Can write basic validation documents
Understand all data integrity principles
Ready for practical application
💼 PHASE 3: PRACTICAL SKILLS (Weeks 9-12)
Goal: Create portfolio documents, learn advanced topics, prepare for job market
Week 9: Practice – Create Your URS
Day 1-3: Draft URS Document
Choose system: HPLC, Balance, or LIMS
Write document title and approval header
Write Purpose section (2-3 paragraphs)
Write Scope section (what’s included/excluded)
List 15-20 user requirements
Include: Functional requirements
Include: Regulatory requirements
Include: Technical requirements
Day 4-5: Refine Your URS
Review against downloaded template examples
Ensure all requirements are testable
Add regulatory references (Part 11, GMP)
Check grammar and professional formatting
Add document control information
Save as professional PDF for portfolio
Day 6-7: Learn from Failures
Search: “FDA warning letters CSV failures”
Read 5 different warning letters thoroughly
Identify what went wrong in each case
List lessons learned from each
Write 1-page summary of common mistakes
✓ Week 9 Checkpoint:
Have completed sample URS document
Document is professionally formatted
Learned from real regulatory failures
Week 10: Practice – Create IQ/OQ Protocols
Day 1-3: Create IQ Protocol
Use same system as Week 9 URS
Write protocol header with approval page
Write Purpose, Scope, Responsibilities sections
Create 15-20 IQ test cases
Include: Hardware verification checks
Include: Software installation verification
Include: Documentation review
Create test execution results table
Day 4-5: Create OQ Test Cases
Write 20-25 OQ test cases
Include: Operating range tests
Include: Alarm and alert testing
Include: Security and access control tests
Include: Audit trail functionality tests
Write clear acceptance criteria for each test
Day 6-7: Create Traceability Matrix
Link URS requirements to IQ/OQ test cases
Use Excel spreadsheet format
Ensure 100% requirement coverage
Identify any gaps in testing
Update test cases to cover all gaps
Add to professional portfolio
✓ Week 10 Checkpoint:
Have complete IQ/OQ protocols created
Traceability matrix is 100% complete
All tests are clear and executable
Week 11: Advanced CSV Topics
Day 1-2: Cloud Validation
YouTube: “Cloud validation pharmaceutical”
YouTube: “SaaS validation GAMP 5”
Understand vendor assessment requirements
Learn about shared responsibility model
Write 1-page summary on cloud CSV challenges
Day 3-4: Vendor Audits
YouTube: “Supplier audits pharmaceutical”
YouTube: “Vendor questionnaire CSV”
Understand: What to check in vendor audits
Create checklist of 20 vendor audit questions
Understand vendor documentation requirements
Day 5-7: Change Control & Periodic Review
YouTube: “Change control GxP systems”
YouTube: “Periodic review computerized systems”
Understand: When revalidation is needed
Learn about change risk assessment
Study periodic review requirements and frequency
✓ Week 11 Checkpoint:
Understand modern validation challenges
Can assess cloud/SaaS systems
Know change control principles
Week 12: Networking & Job Preparation
Day 1-2: Join LinkedIn Groups
Join: “Computer System Validation Professionals”
Join: “GAMP 5 Community”
Join: “Pharmaceutical Quality Assurance”
Join: “GxP Compliance Network”
Join 1-2 additional relevant CSV groups
Introduce yourself in each group
Day 3-4: Update LinkedIn Profile
Update headline: “Aspiring CSV Specialist | Pharmaceutical Validation”
Add skills: CSV, GAMP 5, 21 CFR Part 11, Data Integrity
Add skills: IQ/OQ/PQ, Validation Documentation
Add certifications: List all completed courses
Write professional summary highlighting CSV knowledge
Mention portfolio of validation documents
Day 5-7: Interview Preparation
YouTube: “CSV interview questions and answers”
Prepare answers to 20 common CSV questions
Practice explaining GAMP 5 categories clearly
Practice explaining validation lifecycle
Record yourself answering interview questions
Review and improve your responses
✓ Phase 3 Complete – Major Checkpoint:
Have professional portfolio documents (URS, IQ, OQ)
LinkedIn profile is optimized and professional
Ready for job interviews
Actively networking with CSV professionals
Ready for job search phase
🚀 PHASE 4: JOB SEARCH & CONTINUOUS LEARNING (Weeks 13-16+)
Goal: Build portfolio, apply for jobs, land your first CSV role
Week 13: Portfolio Finalization
Create Professional Portfolio Package
Create CSV portfolio folder (digital)
Organize: URS document
Organize: IQ protocol
Organize: OQ protocol
Organize: Traceability matrix
Create 1-page case study of validation project
Design professional portfolio cover page
Save entire package as PDF
Expand Your Knowledge
Take 2 more free Udemy courses on related topics
Read 5 recent pharmaceutical industry articles
Watch 5 advanced CSV YouTube tutorials
Study emerging topics: AI/ML validation
Week 14: Resume & Job Search Setup
Resume Optimization
Create CSV-focused resume
Add CSV skills prominently in skills section
List all courses completed (include free ones)
Mention portfolio of validation documents
Include: GAMP 5, 21 CFR Part 11, Data Integrity knowledge
Tailor resume for “Validation Specialist” roles
Have 2-3 people review your resume
Set Up Job Alerts
Indeed: Set alert for “CSV validation”
Indeed: Set alert for “Computer System Validation”
LinkedIn: Set job alert for “Validation Specialist”
LinkedIn: Set alert for “Quality Assurance pharmaceutical”
Check pharmaceutical company career pages directly
Join contract staffing agencies (Kelly, Aerotek)
Week 15: Active Job Applications
Apply Strategically
Apply to 10-15 entry-level CSV positions
Target: Validation Specialist roles
Target: Quality Assurance Associate positions
Target: Junior CSV Consultant roles
Target: Compliance Specialist positions
Customize each application to job description
Follow up on applications after 1 week
Interview Readiness
Practice 20 CSV interview questions daily
Have portfolio ready to share (PDF + printed)
Prepare 10 questions to ask employers
Research each company before interviews
Practice explaining your self-study journey
Week 16+: Continuous Learning & Growth
Stay Current
Follow FDA.gov for regulatory updates
Read pharmaceutical news weekly
Participate actively in LinkedIn discussions
Watch new CSV tutorial videos monthly
Read industry publications (Pharma Technology)
Plan Your Career Growth
Once employed: Request ISPE certification sponsorship
Seek mentorship from senior validators
Volunteer for CSV projects at work
Build expertise in specific system types
Consider specializing: Cloud, AI/ML, or Medical Devices
Plan for advanced certifications (ASQ, PMP)
📊 MASTER PROGRESS TRACKER
Knowledge Milestones
Can explain 21 CFR Part 11 confidently (5+ min)
Understand all 5 GAMP categories with examples
Can draw and explain complete V-model
Know difference between IQ, OQ, PQ thoroughly
Understand and can explain ALCOA+ principles
Can write professional validation documents
Can create complete traceability matrices
Understand vendor assessment requirements
Know change control and revalidation triggers
Familiar with cloud/SaaS validation challenges
Practical Achievements
Completed minimum 1 free online CSV course
Watched 20+ hours of educational videos
Created professional URS document
Created complete IQ protocol
Created complete OQ protocol
Built traceability matrix linking requirements to tests
Have organized, comprehensive study notes (50+ pages)
Built professional CSV portfolio package
LinkedIn profile is fully optimized
Actively networking in 5+ LinkedIn groups
Job-Ready Status
Can confidently answer 20 CSV interview questions
Have applied to 10+ relevant positions
Can discuss my self-study journey professionally
Have portfolio examples ready to share
Understand entry-level CSV job responsibilities
Know career progression path in CSV field
Connected with CSV professionals for networking
Resume is tailored for validation roles
Weekly Study Log
| Week | Hours Studied | Topics Covered | Confidence (1-10) |
|---|---|---|---|
| 1 | |||
| 2 | |||
| 3 | |||
| 4 | |||
| 5-8 | |||
| 9-12 | |||
| 13-16+ |
📖 QUICK REFERENCE GUIDE
Key Definitions to Memorize
CSV: Computer System Validation – documented evidence that a computerized system does what it’s designed to do in a consistent, reproducible manner
GAMP 5: Good Automated Manufacturing Practice – risk-based approach to validation
21 CFR Part 11: FDA regulation for electronic records and electronic signatures
ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available
IQ: Installation Qualification – verification that system is installed correctly
OQ: Operational Qualification – verification that system operates as intended
PQ: Performance Qualification – verification under actual operating conditions
GAMP 5 Software Categories
Category 1: Infrastructure software (OS, databases)
Category 3: Non-configured products (standard commercial off-the-shelf)
Category 4: Configured products (configurable commercial products)
Category 5: Custom applications (bespoke/custom software)
Note: Categories 2 (firmware) is less commonly used
Essential Free Resources URLs
• FDA 21 CFR Part 11: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
• EU Annex 11: health.ec.europa.eu/medicinal-products/eudralex_en
• Free Courses: www.udemy.com (search “CSV pharmaceutical free”)
• Articles: www.learnaboutgmp.com
• Webinars: www.validationcenter.com
Top 10 Interview Questions to Prepare
What is Computer System Validation?
Explain the GAMP 5 software categories
What is 21 CFR Part 11?
Explain the difference between IQ, OQ, and PQ
What are ALCOA+ principles?
What is a traceability matrix?
When is revalidation required?
What is risk-based validation?
What documents are needed for CSV?
How do you validate a cloud-based system?
💪 STAY MOTIVATED!
Remember Your Why
You’re investing 16 weeks to launch a rewarding career in pharmaceutical validation.
Entry-level CSV roles typically pay: $50,000 – $75,000/year
Experienced CSV specialists earn: $80,000 – $120,000+/year
Every checkbox you complete brings you closer to your goal!
Success Tips
✓ Study consistently (1-2 hours daily is better than 10 hours once)
✓ Take good notes (you’ll reference them for years)
✓ Practice documentation (this is your main job skill)
✓ Network actively (many jobs come through connections)
✓ Stay curious (the field is always evolving)
✓ Be patient (mastery takes time and practice)
📝 PERSONAL NOTES & REFLECTIONS
Use this space to track your journey, insights, and progress
Week 1-4 Reflections:
Week 5-8 Reflections:
Week 9-12 Reflections:
Week 13-16+ Reflections:
Key Learnings & Breakthrough Moments:
Challenges Overcome:
Career Goals (6 months, 1 year, 3 years):