JGTA Whitepaper: “Applying Human Performance Models in FDA Regulated Environments”
One of the things I like about delivering web courses is that I get to speak and interact with people I might otherwise not come into contact with. After a webinar on reacting to human error, one of the attendees had a discussion with their management – and had questions from that meeting they sent me, looking for some guidance.
The exercise of applying the human performance models to the GMP environment was well worth the time, and led to a broader discussion of melding the two worlds.
This white paper combines the two halves of the article as published on Pharmaceutical Online:
- Part 1 addresses regulatory approach, confidentiality, and correcting an actual FDA 483 observation addressing human performance.
- Part 2 explains what “human errors” truly are, when CAPA is (or should be) required, and how to get started using human performance improvement tools.