ARTICLES BY JAMES VESPER
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![Risk-Assessment-Risk-Analysis-GettyImages-1193956489]( "What Are Risk Appetite & Risk Tolerance In Pharma & Medical Devices?")
What Are Risk Appetite & Risk Tolerance In Pharma & Medical Devices?2/23/2022This 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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![iStock-680899174]( "Critical Thinking In Root Cause Investigations: Asking The Right Questions")
Critical Thinking In Root Cause Investigations: Asking The Right Questions7/27/2020As 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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![Meting Of Minds]( "Decisions In A COVID-19 World: Combat Stress With Quality Risk Management")
Decisions In A COVID-19 World: Combat Stress With Quality Risk Management4/22/2020Few 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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![People Typing At Laptops]( "Facilitating Great Virtual Meetings During A Pandemic (Or Any Other Time)")
Facilitating Great Virtual Meetings During A Pandemic (Or Any Other Time)3/20/2020Even 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.
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![Checklist]( "Facilitating Data Integrity Through Risk-Based Confirmation Of Performance")
Facilitating Data Integrity Through Risk-Based Confirmation Of Performance10/2/2019We in pharma and biopharma are required to verify or check or double-check an action or event to be sure it was performed and performed correctly. But what do these words really mean? How do they differ in terms of their actual execution?
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![Quality Risk Management 101: Overcoming Common Challenges In QRM Implementation]( "Become A (Better) Facilitator For Risk Assessment And Root Cause Analysis")
Become A (Better) Facilitator For Risk Assessment And Root Cause Analysis2/28/2019When SMEs, management, and others gather to perform a risk assessment or a root cause analysis on a failure, they’re sure to achieve the desired outcome, right? Perhaps for a simple risk assessment or investigation, but success is not very likely for one that is even moderately complicated. That’s where a skilled facilitator is needed.
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![Training_450x300]( "Regulatory GMP Expectations For Learning, Training, & Performance In Pharma")
Regulatory GMP Expectations For Learning, Training, & Performance In Pharma9/10/2018Having a competent, professional workforce is essential to meeting the dual goals of business requirements and regulatory expectations. With a coherent plan and a well-structured learning system that is focused on performance, a pharma firm can efficiently accomplish both.
James Vesper
James Vesper, Ph.D., MPH, is a director at ValSource with a focus on learning, training, quality risk management, and error investigation. With more than 35 years of pharma experience, he began his career with Eli Lilly and Company and then started the consulting firm LearningPlus. Vesper has worked globally with pharma firms, regulatory agencies, and the World Health Organization. He recently completed his sixth book, GMP Root Cause Investigations and Corrective Actions: A Clear and Simple Guide, available from PDA/DHI and was given the PDA’s Distinguished Author/Editor award in 2021. He can be contacted at jvesper@valsource.com.