Mastering Computer System Validation Training Course

Course overview

Ensure your computerised systems are fully compliant, reliable, and designed for long-term success. Mastering Computer System Validation provides a deep dive into the critical discipline that underpins trust in digital pharmaceutical operations. This course moves beyond simple testing to show how a well-structured validation lifecycle proves that your systems perform as intended, every time. You will learn how to establish and maintain systems that generate accurate data, maintain robust audit trails, and secure electronic records for the lifetime of your products.

Regulatory expectations have evolved, and so must your approach. In an era of increasing scrutiny, inadequate validation can lead not only to data integrity breaches but also to costly compliance failures and regulatory findings. Through this course, you will understand how to interpret and apply the principles of EU Annex 11, FDA 21 CFR Part 11, and GAMP®5 with confidence and clarity.

This training transforms CSV from a checkbox exercise into a strategic enabler. You’ll explore how validation supports operational excellence, business continuity, and digital transformation initiatives from traditional on-premise systems to modern AI driven and cloud-based platforms. Real world case studies and interactive exercises ensure the lessons translate directly to your workplace.

By the end of the course, you will have mastered a practical, risk-based framework for computerised system validation that aligns with both regulatory requirements and business objectives. Most importantly, you’ll gain the assurance and authority to lead validation activities that withstand inspection, safeguard data integrity, and inspire confidence across your organisation.

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines.

Benefits of attending

• Gain a comprehensive overview of computer system validation (CSV)
• Enhance your understanding of the key terms used in CSV
• Recognise how Good Practices apply to computerised systems
• Understand the different approaches which might be employed
• Learn how to manage the risk associated with data integrity
• Master Regulatory Frameworks - Gain expert-level understanding of EU Annex 11, FDA 21 CFR Part 11, and GAMP 5 principles
• Practical Risk-Based Approach - Learn to streamline validation without compromising compliance
• Inspection Readiness - Develop documentation and strategies that satisfy inspectors globally
• Future-Proof Skills - Understand CSV in the context of AI, SaaS, and data integrity challenges
• Real-World Application - Apply your knowledge to authentic case studies from pharmaceutical operations

Who should attend

• Quality management specialists
• Pharmaceutical validation professionals
• Pharmaceutical project managers
• Computer system engineering specialists

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