CSV Fundamentals – GAMP5, Annex 11 and Data Integrity in Practice

Your practical entry point into Computer System Validation – understand regulations, validation lifecycle concepts and modern GMP expectations in one compact digital training

• Understand the fundamentals of GMP-compliant Computer System Validation

• Learn how ISPE GAMP5, Annex 11 and 21 CFR Part 11 apply in practice

• Build a strong foundation for validation, data integrity and digital compliance

Computerized systems are essential throughout pharmaceutical and life science operationsfrom manufacturing and laboratories to quality systems, logistics and clinical environments. At the same time, regulatory expectations regarding data integrity, system reliability and documented compliance continue to increase globally.

This one-day digital training provides a practical introduction to Computer System Validation (CSV) and the key international regulations governing computerized systems in regulated industries. Participants will gain a clear understanding of validation principles, system lifecycle concepts, roles and responsibilities, as well as current expectations from authorities and inspectors.

The seminar covers the most important regulatory frameworks including ISPE GAMP5, EU GMP Annex 11, US FDA 21 CFR Part 11 and the emerging EU GMP Annex 22 for Artificial Intelligence (draft version). In addition, participants will learn how CSV principles apply across different regulated areas such as GCP, GLP, GDP, GVP and medical devices.

Designed as a compact base camp for CSV, this training establishes the foundation for further specialization in validation, digitalization and compliance projects.

Content

• Fundamentals of Computer System Validation (CSV)

• GMP basics for computerized systems

• Introduction to ISPE GAMP5

• EU GMP Annex 11 requirements

• US FDA 21 CFR Part 11 overview

• Introduction to EU GMP Annex 22

• Roles and responsibilities in CSV projects

• Validation lifecycle approach

• Documentation and compliance expectations

• Data integrity fundamentals

• CSV considerations for:

  • GCP

  • GLP

  • GDP

  • GVP

  • Medical Devices

Learning Objectives

• Understand the fundamentals of Computer System Validation

• Interpret key regulations and guidance documents relevant to CSV

• Understand roles and responsibilities within validation projects

• Learn the validation lifecycle approach for computerized systems

• Gain awareness of data integrity and compliance expectations

• Build a foundation for advanced CSV and digital compliance topics

Target Audience

• Professionals working in CSV, IT and digitalization

• Quality Assurance and Quality Management personnel

• Validation specialists and project managers

• Employees working with computerized systems in regulated environments

• Beginners and professionals entering the field of CSV

• Professionals from GMP, CGMP, GCP, GLP, GDP, GVP and medical device environments

Special Features

• Compact one-day digital training format

• Practical introduction to modern CSV requirements

• International regulatory perspective

• Ideal entry-level seminar for further CSV specialization

• Focus on real-world implementation and inspection readiness

Industries

• Pharmaceutical industry

• Biotechnology companies

• Medical device industry

• CROs and laboratory organizations

• GMP-regulated manufacturers and service providers

TrainerMarkus Roemer, comes compliance service