ARTICLES BY JAMES VESPER
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What Are Risk Appetite & Risk Tolerance In Pharma & Medical Devices?2/23/2022
This article describes and differentiates risk appetite and risk tolerance and discusses why these two concepts are foundational to how we make risk-based decisions in pharma and medical devices. Also covered are a spectrum for risk appetite, best practices for risk communication, and events and conditions that can shape risk appetite and tolerance.
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Critical Thinking In Root Cause Investigations: Asking The Right Questions7/27/2020
As we write or review a root cause investigation, it is up to each of us to challenge the information we are given, and ensure it stands up to a critical analysis.
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Decisions In A COVID-19 World: Combat Stress With Quality Risk Management4/22/2020
Few of us have ever lived with so much uncertainty and lack of knowledge as we are facing now. This article explains why a structured approach for making risk-based decisions is so important, particularly when we find ourselves in stressful conditions with conflicting needs on many fronts.
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Facilitating Great Virtual Meetings During A Pandemic (Or Any Other Time)3/20/2020
Even before the global pandemic of the novel coronavirus, virtual meetings were on the rise, With a large percentage of people working from home, it's now a public health imperative. Here's how to facilitate a risk assessment, root cause investigation, or something similar via “virtual facilitation” with team members and subject matter experts scattered around the world.