Red Nucleus Training Institute
Providing on-demand training solutions
Data Integrity Controls: Quality Control Out-of-Specification Investigations
Data Integrity Controls: Quality Control Out-of-Specification Investigations
~0.50 hrs | GMP - Quality SystemsManagement of out-of-specification (OOS) results is a critical factor to ensure data integrity and is often cited during inspections. This module will provide you with a foundational understanding of how to establish data integrity controls and investigate OOS issues.
Module Details
After completing this module, you will be able to:
• State common data integrity concerns that are cited in the laboratory, FDA Form 483s, and/or in Warning Letters
• List expectations for laboratory out-of-specification management
Features
• Audio narration with on-demand full-text transcript
• Module-level interactive learning exercises and
self-check questions
• Fully cited and sourced from a blend of Red Nucleus
best practices and global health authority regulations
and guidance
• Updated annually
• SCORM compliant
Interested in learning more about this course?