CAPA

Introducing the DIGR-ACT® Solution! Part 6

7/09/2019

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What does ‘C’ stand for?

Do you care whether the actions you took to try to stop an issue from recurring were completed? Does it matter if they actually worked? Of course! Deciding on actions is only part way to fixing a problem. We need to complete the actions and make sure they were effective. That's why there is the ‘C’ step in the DIGR-ACT® solution, where C stands for ‘Check’.

Introducing the DIGR-ACT® Solution! Part 4

6/04/2019

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What does ‘R’ stand for?

We're all in a rush, and we want to fix issues quickly. But often, by assuming too much, we might reach the wrong conclusion. The cause that we used root cause analysis tools to discover is actually incorrect. Once we have the (wrong) cause(s), we may rush off and take action to fix it. But if it's the wrong cause, it is wasted effort and you rushed - only to go slow. Like if your taxi doesn't show, you might decide never to use that company again because they are unreliable - when the real problem was that you gave them the wrong pick-up address.

Introducing the DIGR-ACT® Solution! Part 3

5/07/2019

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What does ‘G’ stand for?

W. Edwards Deming said, "If you can't describe what you're doing as a process, you don't know what you're doing!" Many people don't naturally think of work as a process, but thinking of it that way can help you uncover what might be an earlier cause of something going wrong. Maybe your normal process for grocery shopping is to write a shopping list and take it with you to the grocery store to make sure you get all the items. But today, you get home and realize you are missing several items you needed.

Can You Dig Down to the Root Cause?

4/30/2019

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You have probably heard about the changes to the ICH E6 GCP, the R2 addendum, and that it impacts clinical trial oversight. One particularly important section added was in ICH E6 (R2) 5.20.1: “If noncompliance that significantly affects or has the potential to significantly affect human subject protection or reliability of trial results is discovered, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions.”

Free Live Webinar May 7: Critical Thinking In Clinical Research – A Better Way

4/18/2019

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Topic: Critical Thinking in Clinical Research and DIGR-ACT®

Date: May 7, 2019, space is limited to 100 participants! Sign-up Early.

Time: 11:00 a.m. – 12:00 p.m. EDT

Duration: 60 minutes

Sponsored by: Life Science Training Institute

Webinar: Live interactive session. Recording will be available for 30 days.

Sign up here.