Program Scope

This training program provides a comprehensive understanding of global regulatory requirements for Computerized System Validation (CSV), electronic records, and electronic signatures. It integrates the principles of the GAMP 5 lifecycle approach, including specification, verification, risk management, and operational controls. The program addresses requirements from major regulatory bodies, including the FDA and the EU, and incorporates industry best practices to maintain data integrity throughout the entire system lifecycle, from concept to retirement. This program emphasizes practical application through detailed case studies.

Learning Objectives

Upon successful completion of this program, participants will be able to:

• Interpret and apply the core regulatory requirements for electronic records and signatures in GxP environments.
• Implement the five key concepts of GAMP 5: Product and Process Understanding, Lifecycle Approach, Scalable Lifecycle Activities, Science-Based Quality Risk Management, and Leveraging Supplier Involvement.
• Execute a risk-based validation strategy for various system types, including standard off-the-shelf products, configured products, and custom applications.
• Establish and maintain a computerized system in a validated state during the operational phase, including change control and periodic review.
• Design and manage critical validation documentation, including Validation Plans, User Requirements Specifications, and Traceability Matrices.
• Apply critical thinking to scale compliance activities according to system complexity, novelty, and potential impact on patient safety.

Target Audience

• Quality Assurance and Quality Control Personnel
• Validation Specialists and Engineers
• IT and Laboratory System Administrators
• Automation Engineers and Process Owners
• Regulatory Affairs Professionals
• Clinical Research Associates and Data Managers
• Consultants and Suppliers to the Pharmaceutical, Biotech, and Medical Device Industries

Certification

Participants will be awarded a Certificate of Completion for the “Global CSV and GAMP 5 Mastery Program” after successfully passing all module-level assessments with a score of 80% or higher. This certification demonstrates a practitioner-level understanding of global CSV principles, risk-based validation, and GAMP 5 methodologies.