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.

 
 

What you will learn

  • 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

Read more:
⦁ System Life Cycle
⦁ 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

  • I am very satisfied with the services provided.
    Deborath Salamonczyk
    Hebe's - (05/2026)
  • The team at FIVE demonstrated exceptional professionalism throughout this project. They were consistently encouraging, supportive, and highly effective in executing the validation activities to the highest standards. I look forward to collaborating with them on future projects. On behalf of the entire Galderma team, we sincerely appreciate FIVE’s guidance, commitment, and support throughout this engagement.
    Markieta Stevens
    Galderma - (04/2026)
  • "I am very pleased with the quality and speed of service for open tickets in the Go!Five system. This effective and efficient support allows us to pass these qualities on to our operations and deliveries. Keep up the good work!"
    Murilo Knop
    Catarinense - (02/2026)
  • "I appreciate all the support and professionalism that went into delivering this project, which is so important to the company."
    Karina Souza
    Rio Biofarma - (03/2026)
  • "I have enjoyed working with the team at FIVE and I am looking forward to future projects with this team."
    Markieta Stevens
    Galderma - (02/2026)
  • "It is a company that has been validating the Omni system for years and has always delivered high-quality service. "
    Victoria Miranda
    Takeda - (02/2026)
  • "I can say that GO!FIVE® is a very good solution for the validation process and that it makes work much easier. Almost everything the user needs is available and well structured."
    Maja Petinac
    Infinus - (01/2026)
  • "We express our satisfaction with the service provided, which fully met our expectations and requirements. We highlight the high technical quality and consistency of the risk analysis conducted throughout the work, demonstrating in-depth regulatory, methodological, and operational knowledge."
    Simone Fernandes
    Bio-Manguinhos - (01/2026)
  • "FIVE was essential in enabling us to conduct this validation satisfactorily. I would like to congratulate the team for their organization, clarity in the steps, and willingness to assist us with any questions we had. Without a doubt, it was a time of great exchange and learning, and I would recommend FIVE to any laboratory wishing to implement and validate a new system."
    Mayara Sá
    Bio-Manguinhos - (01/2026)
  • "The project was completed successfully and with commitment."
    Jéssica Alves
    Solabia - (12/2025)
  • "Excellence in service provided"
    Eliane Aguiar
    Takeda - (12/2025)
  • "Excellent work by FIVE, all the support provided was sensational! Everyone involved was patient, available, helpful, and objective. They clarified all doubts and suggested possibilities, always with justification and high-level technical knowledge."
    Fernando Alves
    Besins Healthcare - (12/2025)
  • FIVE presented a solid technical foundation, resulting in a robust and safe project.
    Helda Machado
    Fagron - (11/2025)
  • The project was handled very well by Fagron's validation team. We have always relied on FIVE's expertize for our projects, which is why Fagron has been a FIVE partner for over 8 years. Here's to the next projects!
    João Mendes
    Fagron - (11/2025)
  • I only took part in the project for a short time, in the final stages of the reports, but I was satisfied with the support provided and the guidance given. Meetings were agile and clear about the objective.
    Paôla Oliveira
    ADCOS - (09/2025)
  • Exceptional service.
    Luana Lemes
    R2PHARMA - (09/2025)
  • FIVE specialist has always been very prompt with her deliveries
    Victoria Miranda
    Takeda - (02/2025)
  • The quality of the services provided by FIVE was excellent, deadlines were met and the necessary support was provided. The professionals demonstrated in-depth knowledge of validation processes and helped us through a number of challenging scenarios.
    Eliane Aguiar
    Takeda - (02/2025)
  • It was a very valuable training for me, especially in the automation part, which I didn't know much about.
    Ingrid Oliveira
    Fresenius Kabi - (12/2022)
  • Very productive contents.
    Breno Gine
    Ibramed - (05/2023)
  • Very valuable content.
    Juliano Oliveira
    Ibramed - (05/2023)
  • Very didactic and attentive tutor. Congratulations.
    Lucas Reinaldi
    Forlogic - (02/2020)
  • I chose FIVE due to the good reputation in the market and due to previous participation in trainings that were very well conducted.
    Gabriela Sanches
    Boehringer Ingelheim - (07/2023)

Do you have any questions?

Please, contact us at:

[email protected]

or access the FAQ.

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/.