- State what the cGMPs imply regarding human errors.
- State the FDA's current thinking about human errors and deviations.
- Describe the basics of root cause determination.
- List the possible root causes to human errors.
1. Activity: Heard on the street
2. What the FDA says about human errors and deviations
3. How many human errors are too many
4. Recent 483 observations relating to human error
Understanding human error
1. The psychology of human error
2. Sources of human error
Investigating human error
1. Activity: A simple human error
3. Sequence of events
5. Walk through analysis
6. Fish bone diagramming and root cause analysis
7. Types of root causes
Preventing human errors
1. CAPA (Corrective Action and Preventive Action)
2. Control barrier analysis
3. CGMP Challenge: Human Errors
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