A comprehensive, hands-on training program designed to equip professionals with the knowledge and practical skills needed to validate computerized systems in regulated life sciences environments. This course bridges regulatory requirements with real-world implementation, ensuring you can effectively manage validation projects from planning through ongoing compliance.

Course Description This course provides in-depth knowledge and practical guidance on managing Out-of-Specification (OOS) results in accordance with FDA, EU GMP, and ICH expectations. Participants will learn how to properly identify, investigate, document, conclude, and trend OOS results while ensuring data integrity and regulatory compliance.

This foundational course translates the regulatory requirements of Good Manufacturing Practices (GMP) into practical, everyday principles. Participants will move beyond memorizing rules to understanding the "why" behind them, enabling informed decision-making and robust quality culture in roles spanning manufacturing, quality control, warehousing, and engineering.