Lesson Code: OPE-1103 (Premium Lesson) This e-Lesson is aimed at personnel in GMP-regulated manufacturing facilities who require an overview and understanding of errors and their impact on GMP-regulated environments, as well as the measures that can be taken to manage these errors and reduce the likelihood of their reoccurrence.

  • Category: Errors in GMP Manufacturing


After taking this e-Lesson, you will be able to:

  • Define 'error' as it applies to human behavior in GMP-regulated environments
  • Explain the relevant industry regulations that relate to errors and their investigation
  • Distinguish between skill-based, rule-based, and knowledge-based errors
  • Provide examples of errors that can arise in a GMP manufacturing environment
  • Explain why 'human error' is not a valid root cause
  • Outline various approaches for determining root cause(s) of errors
  • Explain reactive and proactive approaches to error management