ARTICLES BY BEN LOCWIN
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![GettyImages-1304568402]( "SOPs, The Modern Worker & How Pharma Companies Must Evolve The “Read & Understand” Model")
SOPs, The Modern Worker & How Pharma Companies Must Evolve The “Read & Understand” Model6/1/2022Pharma companies have used “read and understand” approaches with standard operating procedures (SOPs) as a core component for staff training for many years. However, what is the percentage of people who are completing their read and understand assignments without truly understanding them? We need to evolve our model of SOPs.
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![Stealing Money From Computer]( "Advanced Computing In Pharma & Medtech: How Cognitive Biases Can Cost You Millions")
Advanced Computing In Pharma & Medtech: How Cognitive Biases Can Cost You Millions11/11/2020In their race to leverage sophisticated computing technologies (particularly artificial intelligence, robotics, augmented/virtual reality, and IoT), life science companies face a hidden, insidious challenge — avoiding the cognitive biases that can cause them to unwittingly exacerbate already business-threatening cyber risks.
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![Fail]( "FDA's Drug Shortages Root Cause Report: Does It Miss The Mark?")
FDA's Drug Shortages Root Cause Report: Does It Miss The Mark?2/7/2020At the behest of Congress, an inter-agency Drug Shortage Task Force, led by the FDA, published the "Drug Shortages: Root Causes and Potential Solutions" report. The very first root causes listed in the report are “economic forces,” but there's a lot more to the story.
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![“Human Error” Deviations: Why You Should Stop Creating (Most Of) Them]( "“Human Error” Deviations: How You Can Stop Creating (Most Of) Them")
“Human Error” Deviations: How You Can Stop Creating (Most Of) Them10/9/2017In the time it takes you to read this article, the industry will generate (conservatively) about 115 new process deviations, and about 65 of them will be misclassified as having something related to “human error” as either the principal causal factor or one of the proximal causal factors.
Ben Locwin
Ben Locwin, Ph.D., MBA, M.S., is a pharma executive and a member of several advisory boards and boards of directors across the industry and was the former president of a healthcare and pharma consulting organization. He created many of the frameworks for risk management currently in use within the industry and has worked across the drug life cycle from early phase to commercial manufacturing and marketing (GLP, GCP, GVP, GMP). He frequently keynotes events and conferences on these current topics.