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 started his career with Eli Lilly and Company and then started the consulting firm LearningPlus. He has worked globally with pharma firms, regulatory agencies, and the World Health Organization. He has just completed his sixth book, GMP Root Cause Investigations and Corrective Actions: A Clear and Simple Guide, available this summer from PDA/DHI. He can be contacted at jvesper@valsource.com.
ARTICLES BY JAMES VESPER
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![iStock-680899174]( "Critical Thinking In Root Cause Investigations: Are You Asking The Right Questions?")
Critical Thinking In Root Cause Investigations: Are You Asking The Right Questions?As we write or review a root cause investigation, it is up to each of us to challenge the information we are given and see if it stands up to having a critical light shined on it.
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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 ManagementFew 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)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.
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![Checklist]( "Facilitating Data Integrity Through Risk-Based Confirmation Of Performance")
Facilitating Data Integrity Through Risk-Based Confirmation Of PerformanceWe 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 AnalysisWhen 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 PharmaHaving 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.
