Build Your Future in CSV & Quality Compliance
Develop practical knowledge of Computer System Validation, pharmaceutical quality systems, regulatory compliance, data integrity, and risk-based validation through a structured learning programme — designed for pharmaceutical and life sciences professionals.
MEASURABLE OUTCOMES
What Will You Learn by the End of This Program?
- Understand GxP, GMP, GDP, and Data Integrity requirements
- Apply FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP 5 principles
- Develop and review validation deliverables including URS, RA, ER/ES, IQ, OQ, PQ, TM, and VSR
- Perform risk assessments using industry-standard methodologies
- Understand audit trails, electronic records, and electronic signatures
- Execute qualification protocols and validation activities
- Manage deviations, CAPA, and change control processes
- Interpret FDA warning letters and inspection expectations
- Support validation projects in regulated environments
- Build a job-ready resume, prepare for CSV technical interviews, and confidently face interviews
₹ 20,000 ₹ 25,000
Get Complete Access to Video Modules, Practical Resources, Assessments & Industry Certification.
Whats included ?
✓ 18 Structured Video Modules
✓ CSV Templates & Validation Walkthroughs
✓ Module-Wise Assignments & Validation Exercises
✓ Mentoring Sessions & Career Development Support
✓ Exclusive Complimentary Bonus Resources
Certificate of Completion
Structured Curriculum
Learning Hours
Program Duration
ACADEMIC EXCELLENCE
What Makes This Program Different?
A structured, practical learning experience that bridges the gap between understanding regulatory requirements and executing real-world validation activities with confidence.
Comprehensive Training
18 Structured Video Modules
From GxP Fundamentals to FDA Inspection Readiness
CSV Project Templates
Validation Walkthroughs using real-world CSV templates
Industry-Backed Expertise
Learn from Avanteva Solutions, an established CSV service provider with experience working with leading pharmaceutical companies.
Practical Assignments
Module-Wise Assignments & Validation Exercises
Flexible Learning & Mentorship
Online Learning
Recorded Sessions Access for Flexible Learning
Weekend Learning Options
Designed for Working Professionals
Mentoring Sessions
Mentoring Sessions & Career Development Support
Exclusive Bonus Resources
CSV Project Guidelines
Practical Guidelines for Validation Engineers Working on CSV Projects
Resume Writing Webinar
Powerful Resume Strategies to Help You Stand Out
Jobsher Career Playbook
Resources to Support Your Career Development
Interview Preparation Guide
Prepare for Interviews with Greater Confidence
CURRICULUM BREAKDOWN
Course Roadmap & Curriculum Details
A 14-week journey from CSV fundamentals to hands-on validation, a capstone project, and career readiness.
WEEK 01 MODULE 01
CSV Career Launchpad & Industry Orientation
TOPICS COVERED
- Program Introduction
- Industry Relevance & Career Pathways
- Learning Objectives
- Key Learning Outcomes
- How CSV Professionals Work in Pharma, CROs & Medical Devices
WEEK 01 MODULE 02
Pharmaceutical Quality Systems & GxP Fundamentals
TOPICS COVERED
- Introduction to Pharmaceutical Quality Systems
- Understanding GxP
- GMP, GDP & Data Integrity
- Role of Computer Systems Across Product Lifecycle
WEEK 02 MODULE 03
Computer System Validation (CSV) Fundamentals
TOPICS COVERED
- What is a Computerized System?
- Operating Environment in CSV
- What is CSV?
- Why CSV is Required
- 3 Pillars of CSV
- Software Validation and Computer System Validation (CSV)
- CSV vs CSA
WEEK 02 MODULE 04
Regulatory Landscape in Computer System Validation (CSV)
TOPICS COVERED
- Regulatory Landscape in CSV
- Consequences of Non-Compliance
- Regulatory Guidelines, Regulatory Guidelines Resource links
- FDA Expectations
- ISPE GAMP 5
- EU Annex 11
- REGULATORY GUIDELINE DOCUMENTS
WEEK 03 MODULE 05
Good Documentation Practices (GDP) & SOP Management
TOPICS COVERED
- Why is Documentation Important?
- What is Good Documentation Practice (GDP)?
- General Rules of Good Documentation Practices (GDP)
- Key Principles of GDP - ALCOA+ Principles
- What is a Standard Operating Procedure (SOP)?
- Key components of an SOP
- SOP Lifecycle
- Managing Controlled Documents & Records
WEEK 03 MODULE 06
Practical CSV Concepts
TOPICS COVERED
- Testing vs Verification
- Qualification vs Validation
- How Testing, Verification, Qualification & Validation Work Together
- How Much Validation Is Enough?
- How to Determine a Validation Requirement?
- Validation is a Lifecycle, Not a One-Time Activity
WEEK 04 MODULE 07
CSV Lifecycle Framework
TOPICS COVERED
- CSV Lifecycle: Project Stages & Stakeholder Roles
- CSV Documentation Matrix
- V-Model
- Validation Approaches Types
- GAMP 5 Drivers
- CSV Deliverables
WEEK 04 MODULE 08
VALIDATION STAGES - Part 1 (VMP & URS)
TOPICS COVERED
- Validation Master Plan (VMP)
- Types of Validation
- VMP Framework
- Validation Master Plan Template*
- User Requirements Specification (URS)
- User Requirements & URS Template*
WEEK 05 MODULE 09
VALIDATION STAGES - Part 2 (IRA & GAMP Categorization, Risk-based approach)
TOPICS COVERED
- Initial Risk Assessment (IRA)
- GxP Assessment, Criticality Assessment, Impact level Assessment
- Validation Strategy
- ER/ES Applicability
- Nature Of System
- GAMP Categorization - Hardware Categorization
- GAMP Categorization - Software Categorization
- Final GAMP Categorization Assessment
- Quality Risk-Management Process
- Software Complexity & Validation Effort
- Risk-Based Approach (Category 3/4/5 products)
- Validation Lifecycle - GAMP Categories
- Validation Deliverables Matrix (Risk-based approach)
WEEK 05 MODULE 10
VALIDATION STAGES - Part 3 (PVP)
TOPICS COVERED
- Project Validation Plan (PVP)
- Project Validation Plan (PVP) Template*
- Validation Strategy & Lifecycle Approach
- Validation Approach
- V-Model & Validation Deliverables
- Validation Stages (1): URS-IRA-ER/ES-RA-FS-DS
- Validation Stages (2): IQ-OQ-PQ
- Validation Stages (3): TM-VSR
- Change Control Process
- Deviation Management
- Incident & Problem Management
- Periodic Review, Backup & Restoration
- Data Integrity and Security, System Maintenance, System Retirement / Decommissioning, Training
WEEK 06 MODULE 11
VALIDATION STAGES - Part 4 (RA)
TOPICS COVERED
- Introduction
- Risk Assessment Template
- Scope, Roles & Responsibilities
- FMEA Risk Assessment Methodology
- Likelihood/Probability
- Severity
- Detectability
- RPN & Residual RPN
- Risk Assessment Documentation - Pre-Mitigation Risk
- Risk Assessment Documentation - Post-Mitigation Risk
- Risk Traceability Matrix
WEEK 06 MODULE 12
VALIDATION STAGES - Part 5 (ER-ES)
TOPICS COVERED
- Introduction
- FDA Definitions: Electronic Records & Electronic Signatures
- ER/ES Types
- Purpose of ER-ES
- Part 11 Applicability
- 21 CFR Part 11 Regulation Overview & Structure
- Key expectations of 21 CFR Part 11
- 21 CFR Part 11 Requirements
- SUBPART A – GENERAL PROVISIONS
- SUBPART B – ELECTRONIC RECORDS
- SUBPART C – ELECTRONIC SIGNATURES
WEEK 07 MODULE 13
VALIDATION STAGES - Part 6 (IQ) - Installation Qualification Protocol (IQP)
TOPICS COVERED
- Introduction, Objective & Purpose
- Prerequisites, Acceptance Criteria
- Test Strategy and Execution Approach
- Test Identification & Numbering Format
- Installation Qualification (IQ) Tests
- Verification of System Identification and Installed System Details, Antivirus / Virus Scan Utility, System Documentation, Communication Interface Configuration, Verification of System Hardware Components
- Verification of Power Supply / Utility, Environmental Conditions
- Verification of System Configuration, User Access Availability
- Verification of Control Panel (General Inspection), Physical and Logical Security, Backup and Restore Utility
- IQ Protocol Development
- Installation Qualification (IQ) Tests Execution
WEEK 07 MODULE 14
VALIDATION STAGES - Part 6 (OQ) - Operational Qualification Protocol (OQP)
TOPICS COVERED
- Introduction, Objective & Purpose
- Prerequisites & Acceptance Criteria
- Test Strategy & Execution Approach
- Typical Structure of OQ Test
- Verification of System Functionality (GUI / Forms / Menu Operations)
- Verification of User Access and Privileges, System Security (Access Control & Authentication)
- Verification of Audit Trail and Event Logging, Date & Time Synchronization
- Verification of Communication and Data Transfer, Power Failure and System Recovery
- Verification of Data Integrity, Storage & Retrieval, Report Generation
- Verification of Error and Exception Handling
- OQ Protocol Development
- Operational Qualification (OQ) Tests Execution
WEEK 08 MODULE 15
Validation Stages - Part 8 (PQ) - Performance Qualification Protocol (PQP)
TOPICS COVERED
- Introduction, Objective & Purpose
- Prerequisites, Acceptance Criteria
- Test Strategy & Execution Approach
- Performance Qualification Tests
- Verification of End-To-End Routine Workflow Execution and Functional Performance
- Post-Mitigation Risk Assessment Review
- PQ Summary & Conclusion
WEEK 08 MODULE 16
Validation Stages - Part 9 - Traceability Matrix (TM) & Validation Summary Report (VSR)
TOPICS COVERED
- Traceability Matrix (TM)
- Importance of TM
- Objective & Purpose
- Traceability Matrix Table
- Validation Evidence Review
- Overall Validation activities Summary & Report
- Deviation Summary, Change Control Summary
- Conclusion
WEEK 09 MODULE 17
CAPA Management & Root Cause Investigation
TOPICS COVERED
- Introduction
- Difference Between Correction, Corrective Action, and Preventive Action
- Why is CAPA Important?
- CAPA Lifecycle Overview
- Sources of CAPA in CSV
- Containment Actions
- Root Cause Analysis (RCA)
- 5 Why Technique
- Fishbone / Ishikawa Analysis
- Fault Tree Analysis (FTA)
- CAPA Effectiveness Verification
- CAPA and Change Control
- CAPA Linkage Across Validation Lifecycle
WEEK 09 MODULE 18
FDA Warning Letters & Inspection Readiness
TOPICS COVERED
- Introduction
- What is an FDA Warning Letter? & Importance
- Difference Between FDA 483 and Warning Letter
- Why FDA Warning Letters are Important in CSV
- Common issues cited in FDA Warning Letters
- Practical examples - Data Integrity Violations, Audit Trail Failures, Shared Passwords and Access Control Issues, Inadequate Computer System Validation, CAPA Deficiencies in Warning Letters, Backup and Disaster Recovery Failures, Poor Change Control Practices
- How Organizations Meet FDA Expectations
- FDA Inspection Mindset
- FDA Warning Letters Database
WEEK 10
Capstone Project (week-1)
WEEK 11
Capstone Project (week-2)
WEEK 12
Complimentary Bonus Resources
WEEK 13
Final presentation
WEEK 14
Assignment/Project Review, Feedback & Final Evaluation, Resume Preparation
Enjoy 20% off for upcoming cohorts. Early bird offer. Limited seats. Claim Spot →
Who Should Enroll?
Freshers
Freshers aspiring to enter regulated pharmaceutical and life science industries
Life science, Engineering & IT graduates
B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Biotechnology, B.Com, M.Com, Chemistry, Life Sciences, Engineering, IT, and related graduates
Working Professionals
Professionals working in QA, QC, Validation, Manufacturing, Regulatory Affairs, Engineering, IT, Clinical Research, and Compliance functions
Career Transitioners
Individuals looking to transition into CSV, Data Integrity, and Quality Compliance roles
Career Pathways
Growing demand for CSV and quality compliance professionals opens doors to specialist and leadership roles across pharmaceutical, CRO, clinical research, and regulatory sectors, spanning validation, quality assurance, and compliance.
CSV Engineer/ Validation Executive
Compliance Specialist
CSV Consultant
Data Integrity Associate
Regulatory Compliance Associate
Quality Assurance (QA) Associate
SkillDash TalentConnect
Connecting Skilled Talent with Industry Opportunities.
A career opportunity initiative by Avanteva Solutions.
Avanteva Solutions is an established Computer System Validation (CSV) and quality compliance service provider, bringing specialized technical expertise and hands-on project experience with leading pharmaceutical, biotechnology and clinical research organizations.
Upon successful completion of the programme, learners can register their profiles in the SkillDash TalentConnect pool. Whenever relevant job openings or project-based opportunities arise within Avanteva Solutions or through its industry network, suitable candidates will be identified from this talent pool and considered based on their qualifications, skills and experience.
Candidate consideration is subject to available openings, eligibility, skills, experience and specific role requirements. Registration does not guarantee employment.
About Us
Avanteva Solutions is a specialized service provider offering Computer System Validation (CSV), quality compliance services to the pharmaceutical, biotechnology, and clinical research industries.
With hands-on industry experience and exposure to the requirements of leading pharmaceutical organizations, we help businesses navigate regulatory expectations and maintain compliant, validated systems.
SkillDash is the learning platform of Avanteva Solutions, leveraging its expertise in pharmaceutical Computer System Validation (CSV) and regulatory compliance to offer industry-certified courses and internships. We help students and professionals bridge the gap between academic knowledge and industry requirements through practical, industry-focused learning that builds job-ready skills for regulated environments.
Frequently Asked Questions
Who is eligible to enrol, and do I need prior CSV experience?
The programme is designed for science, pharmacy, life sciences, engineering, and IT graduates. No prior CSV experience is required — the programme builds knowledge progressively from foundational regulatory concepts through to advanced validation documentation.
How long does the programme take to complete?
The programme is designed for completion in 2–3 months, with a published learning workload of 145 hours across 18 modules. Actual completion time depends on your pace and availability.
Is the programme completely online? Can I learn at my own pace?
Yes. The programme offers recorded online learning, allowing participants to access the modules flexibly. The self-paced format is designed to give working professionals flexibility in when and how they learn.
Will I receive practical assignments and project experience?
Yes. The programme includes module-wise MCQ assessments, short-answer assignments, validation exercises, templates and an industry-style capstone project. Participants also receive feedback and undergo a final evaluation.
Will I receive a certificate after completing the programme?
Yes. Participants who successfully complete the programme will receive a Certificate of Completion from Avanteva Solutions. Receiving a certificate from Avanteva, a proven industry service provider, will help strengthen your profile and improve your chances of getting hired in direct CSV roles.
Does SkillDash provide placement assistance or job opportunities after course completion?
Through SkillDash's TalentConnect initiative, eligible learners can register their profiles in our talent database. Leveraging Avanteva Solutions industry network and business requirements, suitable candidates may be considered for relevant job openings as they arise. This initiative does not guarantee employment or placement.
How can I enrol, and what if I need more information before registering?
You can submit the enquiry form on this page to receive information about the programme, fees and enrolment process. For any questions or additional assistance, feel free to contact us on WhatsApp at +91 99892 54466. Our team will be happy to assist you and guide you through the registration process.
Take the First Step Towards Your CSV Career
Interested in our Computer System Validation (CSV) & Quality Compliance programme? Submit your enquiry and our team will contact you with course details, fees and upcoming batch information.
ENQUIRY FORM
Become an Industry-Certified CSV Professional
Build practical expertise in Computer System Validation and Quality Compliance. Take the next step towards your professional career.
₹20,000 ₹25,000
Limited Early Bird Cohort Seats
© 2026 Avanteva Solutions OPC Pvt. Ltd. All Rights Reserved.