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.

ARTICLES BY JAMES VESPER

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.
Critical Thinking In Root Cause Investigations: Asking The Right Questions
7/27/2020

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.
Decisions In A COVID-19 World: Combat Stress With Quality Risk Management
4/22/2020

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.
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.