Recorded Webinar – Computer System Validation (CSV) – Introduction to General Principles

Overview

Computer System Validation (CSV) or Software Validation is a mandatory regulation from the “Health Canada”, “Food and Drug Administration” (FDA) and the “European Union” (EU) to ensure all the computerized systems or automated data processing systems used in health care industry (Pharma/Medical Devices/Logistics/Warehouse) shall be validated for its intended use according to established pre-defined protocols developed and approved before production use.

The introduction to Computer System Validation module provides the basics of Software Validation, its regulations throughout the life cycle of any computerized systems and the foundation knowledge required to workday- to-day in any regulated health care industry.

This module focuses on the regulations and standards behind CSV, recommendations, and best practices for CSV, understanding the role of GAMP®5 (GAMP5), and the competence required for a validation team. This module includes comprehension and application of the CSV techniques that will result in efficient, effective, and inspection-ready validation initiatives.

Featured Topics

• Introduction to validation
• GAMP 5 principles and categorization
• System Development Life Cycle (SDLC) phases
• Detailed V modal approach
• CSV project deliverables, validation plan, validation protocols (IQ, OQ, PQ), test plans, and test reports
• Guidance on 21 CFR Part 11 concepts
• Understand the FDA and international regulatory landscape around CSV

Learning Objectives:

• Understand current computer system validation regulatory requirements
• Explain the detailed life cycle phase in system development
• Create and review / approve the required validation deliverables
• Understand how to maintain the systems in validated state
• Understand the audit requirements related to Computer System Validation

Who Should Attend

Professionals working in the healthcare, clinical trial, biopharmaceutical, and medical device sectors in areas of:

• Regulatory affairs
• Clinical research
• Marketing
• IT professionals working in the healthcare, clinical trial, biopharmaceutical, and medical device sectors
• Healthcare students who are interested in pursuing their career in validation