Course:
Modern Computer System Validation (CSV) in Life Sciences: GAMP5® 2nd Edition, FDA CSA, and AI/ML Integration
A complete CSV online course
+17 hours on-demand
+100 Lessons
24/7 for 1 year
Access on desktop, mobile, tablet and TV
English
Leaders can purchase multiple licenses, assign them to colleagues, and track their learning progress.
Complete 75% of the content and pass the test to receive your certificate.
- Understanding of Computer System Validation (CSV) principles within a broader context of GxP training.
- In-depth knowledge of Good Automated Manufactuing Practice course and their practical application, aligned with Validation ISPE® training principles.
- Agile methods and digital validation training.
- Cloud system validation training.
- Effective data management, ensuring data integrity and security in validated systems.
- Familiarity with industry regulations, including Annex 11, FDA CSA training, and global standards.
- Insights into Industry 4.0 and trending technologies impacting validation.
- AI ML validation training: how to validate AI/ML-based systems in regulated environments.
- Master the validation process, including procedures, documentation, and maintaining validation status.
Career Impact:
Be prepared to lead or support validation projects aligned with FDA, EMA, and ANVISA, mastering Agile Validation e-learning and paperless / digital approaches.
From Knowledge to Compliance Acceleration:
This training can also be combined with FIVE’s consulting and validation services, creating a complete journey: from learning → to practical application → to full digitalization with GO!FIVE® - what you learn can be applied immediately in the platform, accelerating compliance and results.
Recognized Certification:
Upon successful completion, you will earn a certificate from FIVE Academy, backed by FIVE Validation, a company trusted by over 230 Life Sciences organizations worldwide and certified under ISO 9001:2015 and ISO 27001:2022. This credential strengthens your professional profile internationally and demonstrates compliance readiness for your organization.
About the instructor:

Silvia Martins, an electrical engineer with 23+ years in Life Sciences, specializes in AI validation training, data integrity, and e-compliance. As CEO of FIVE Validation, she created GO!FIVE®, an agile digital solution for regulatory compliance with support of a great team.
Description:
This online course offers over 100 on-demand lessons, covering everything from basic to advanced levels at your own pace. Whether new or experienced, you'll learn about CSV, GAMP5® (2nd edition), FDA CSA, AI Europe Act, agile methods, and data migration. The content is designed to address key regulatory agencies, including EMA, FDA, MHRA, and WHO.
The course covers the Computer System Validation process, agile methods, digital validation strategies, and AI/ML validation, focusing on data integrity, security, and compliance in regulated industries.
With 24/7 access, you can learn anytime. Each short, focused lesson lasts around 10 minutes, making it easy to fit into your daily routine.
And you'll have 1 year of unlimited access to the course across any device, whether it's a computer, tablet, or mobile. This course is perfect for anyone looking to enhance their current skills, learn how to validate AI/ML or begin a career in validation.
This course if for:
• Quality Assurance (QA) professionals
• Regulatory Affairs specialists
• IT and Engineering teams
• Key users
• Project leaders in regulated industries
Regulators are invited to access the FIVE Academy course free of charge, an exclusive opportunity to strengthen your expertise in CSV, AI/ML, and regulatory compliance. Request your free coupon by contacting [email protected]
Program:
• Introduction
• Basic Concepts
• Regulations
• Good Automated Manufacturing Practices (GAMP5® training)
• Holistic Control Strategy
• Validation Concept and Application
• Industry 4.0 and Pharma 4.0
• Trending Technologies/Artificial Intelligence
• Knowledge Management
⦁ Initial Risk Assessment
⦁ Computerized Systems Inventory
⦁ Inventory Scope Suggestion
⦁ IT and OT Infrastructure Qualification
⦁ Validation Master Plan
⦁ Standard Operating Procedures
⦁ Validation Principles
⦁ Artificial Intelligence Life Cycle
⦁ Model Performance Optimization
⦁ Life Cycle of Documents
⦁ Software and Hardware Categorization
⦁ Electronic Record and Electronic Signature (ERES)
⦁ Access Control
⦁ User Authentication and Electronic Signature
⦁ Electronic Record and Audit Trail
⦁ Audit Trail Review
⦁ User Requirement Specification
⦁ Supplier Assessment
⦁ Validation Plan and Quality Plan
⦁ Risk Assessment
⦁ Configuration and Design Specification
⦁ Design Review and Acceptance Testing
⦁ Verification
⦁ Testing phase
⦁ Verification & Validation (V&V)
⦁ FDA CSA (Computer Software Assurance)
⦁ Agile Methods
⦁ Traceability Matrix
⦁ Validation Report
⦁ Business Intelligence (BI) systems
⦁ Artificial Intelligence (AI) Validation
⦁ EU Artificial Intelligence Act
⦁ PAT and Parametric Release
⦁ Electronic Spreadsheets
⦁ Operation and Keeping Validated Status
⦁ Backup and Restore
⦁ Archiving and Retrieval
⦁ Security Management
⦁ System Retirement
⦁ Data Migration
⦁ Responsibilities
⦁ Suppliers Responsibilities
⦁ Challenges of Validation Projects
⦁ Challenges of Validation Projects - Supplier Perspective
Requirements:
• Access to a computer, tablet, or mobile device.
• Reliable internet connection for streaming video content.
Master AI & ML validation: enroll in our machine learning online computer validation course for pharma industry today as part of FIVE Academy’s full CSV training.
The Value We Generate
ISPE® is a registered trademark. All rights reserved.
GAMP5® is a guide that has its intellectual rights reserved by ISPE®. Available for purchase at https://ispe.org/.
















