Errors in GMP Manufacturing
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
Description
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
