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Dan Eagles

Dan Eagles

Jun 15, 2026

10:23
Hmm.
10:23
And so, uh, you know, again, human nature, we do wanna fix things.
10:28
Uh, medical device, you know, we wanna make sure that, uh, patient safety i- is not, uh, is not compromised.
10:36
And so really making sure that when you're assigning a corrective action, it is indeed that action that's gonna prevent recurrence.
10:44
Um, correction to something that, uh, it simply fixes the problem, uh, that's at hand.
10:51
For example, a, a record that doesn't have, uh, maybe some missing fields or some missing data.
10:57
Uh, and so if you do not have a well laid out and simple to operate CAPA system, um, you know, as an auditor myself, you know, I can go in and, you know, start asking, you know, kind of in the investigation and, uh, corrective action phase, implementation phases, "Okay, well, you know, what did this solve? Why did you do this? You know, how does this tie in with your risk management?" Um, um, CAPA and, and risk management are, are, you know, really hand in hand.
15:30
Mm-hmm.

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