Humans make errors, AND, more likely, there are processes and systems that are root causes of setting people up to fail.
This class teaches how to overcome human errors as a root cause to deviations.
Objectives: upon class completion, students will be able to . . .
1. State what the CGMPs imply regarding human errors.
2. State the FDA's current thinking about human errors and deviations.
3. Describe the basics of root cause determination.
4. List the possible root causes to human errors.
- Overview of 483 observations
- Psychology of human failures
- Investigating human errors
- Preventing human errors
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