Blog — Clinical Pathways

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Critical Thinking

Live Webinar: Risk Assessment & CAPA without Tears: The DIGR-ACT® Critical Thinking Solution

8/03/2021

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Date: September 16th OR 23rd, 2021. Choose which date works for you.

Time: 10:30 AM - 12:00 PM EDT

Location: Interactive Webinar

Registration: September 16 Registration HERE September 23 Registration HERE

Cost: AGXPE Member – $79.00

Non-Member Registration – $89.00

Clinical Pathways is pleased to announce a partnership with the Association for GXP Excellence (AGXPE). AGXPE will present the 90-minute interactive webinar hosted by Sam Sather and Keith Dorricott, founders of DIGR-ACT®.

This session will address the challenges in using root cause analysis to lead to effective risk assessment and CAPA for GXP. It will also introduce the challenges and gaps from a process approach standpoint related to integration of essential human performance factors and critical thinking process support. They include highlights of the current significant challenges to performing risk assessment and CAPA without a modern approach to root cause analysis.

These sessions introduce to the GXP audience to DIGR-ACT® as a solution to mature teams and processes in the era of big change.

RBQM Community Discussion Outcomes from MCC vSummit 2020

10/20/2020

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Sandra “SAM” Sather lead a community discussion at Metrics Champion Consortium’s (MCC) vSummit 2020 on “The Risk-Based Monitoring Training Gap,” related to her prerecorded session on “The RBM Training Gap: Risk-Based Monitoring the Noun vs. the Verb.” The conversation was informative as to where different organizations lie on the spectrum of implementing risk-based quality management (RBQM), with attendees from large sponsors explaining that they may have policies that require them to implement 100% source data verification (SDV) regardless of risk assessment for pre-phase III trials and attendees from small to mid-sized organizations commenting that they understand the need for risk-based monitoring plans but sometimes meet challenges cross functionally.

Critical Thinking and Artificial Intelligence

11/14/2019

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In the ever-evolving world of increasing automation, computers and artificial intelligence are taking over jobs that humans use to do. Self-driving cars and home assistant devices may be helpful, but humans are still necessary for their critical thinking skills that artificial intelligence cannot replace.

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 5

6/20/2019

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What does ‘A’ stand for?

Don't waste time on root cause analysis, at least not if you won’t use the results! Proper root cause analysis takes effort and resources, and you need to use the output to determine actions to try to stop the issue recurring. This is the ‘A’ step of the DIGR-ACT® solution. Having dug into the issue, you now need to ‘Act’ on what you found.