Back to Basics: GAMP® 5 Second Edition and the Fundamentals of Computerized System Validation
Complimentary
Learning Level: Basic
Time: 0400 - 0500 ET / 1000 - 1100 CET
Session Length: 1 hour
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Computerized systems underpin almost every activity in the pharmaceutical and life science industry, from research and manufacturing to laboratory testing, quality management, and the supply chain. When such systems are not fit for their intended use, the consequences reach well beyond an audit finding: patient safety, product quality, and the integrity of the data on which critical decisions are based can all be put at risk.
For more than two decades, ISPE GAMP® has provided the industry’s most widely used framework for achieving computerized systems that are fit for intended use, and its approach is recognized by regulatory authorities around the world. The Second Edition of the ISPE GAMP® 5 Guide reaffirmed the underlying principles while refreshing the guidance for modern practice — among other things critical thinking, iterative and incremental development methods, software tools and automation, and the industry’s growing reliance on suppliers and service providers.
This introductory webinar explains what GAMP® is, why it matters to the industry, and what the Second Edition updated. It walks through the basic principles and concepts of computerized system validation — product and process understanding, a scalable life cycle approach within a quality management system, science-based quality risk management, leveraging supplier activities, and critical thinking — and briefly places them in the context of the applicable regulatory expectations. Throughout, the emphasis is on how these principles work together to safeguard patient safety, product quality, and data integrity.
Attendees will leave understanding why GAMP® 5 matters, what its key principles are, how those principles protect patients, and why GAMP® 5 is a sound basis for good practice in their own organizations. The session is intended for anyone new to GAMP® or wishing to refresh their understanding of its fundamentals; no prior knowledge of computerized system validation is assumed.
Learning Objectives
- Explain what ISPE GAMP® is, the role it plays as good industry practice for computerized systems, and what the Second Edition of the GAMP® 5 Guide updated.
- Describe the basic principles and concepts of computerized system validation, including product and process understanding, a scalable life cycle approach within a quality management system, science-based quality risk management, leveraging supplier activities, and critical thinking.
- Recognize how applying these principles safeguards patient safety, product quality, and data integrity, how they relate to the applicable regulatory expectations, and why GAMP® 5 is worth following as guidance for good industry practice.
