ARTICLES BY MARK F. WITCHER
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A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices2/3/2025
Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed.
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System Failure Mode & Effects Analysis (SFMEA): An Alternative Approach For Analyzing Risks6/26/2024
Your company likely uses risk matrices and FMEA for analyzing risks. This article describes an alternative approach for conducting a system failure mode & effects analysis.
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Managing Supply Chain Risks Using Relational Risk Analysis4/5/2024
In the bio/pharma and medical device industries, you can easily model, understand, and manage supply chain risks using relational risk analysis. Here's how.
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Designing Highly Agile Bio/Pharma Manufacturing Facilities4/5/2024
In bio/pharma, agile manufacturing is achieved through multipurpose designs that support a variety of unit operations manipulated and operated as independent yet connected modules.
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Using Relational Risk Analysis To Control Procedure Failures In The Bio/Pharma & Medical Device Industry2/15/2024
In the bio/pharma and medical device industries, operating procedures guide virtually every activity and are required for compliance with good manufacturing practices. Minimizing procedure execution failures is critical. To do so, you can use relational risk analysis (ReRA).
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When In The Product's Life Cycle Does Continuous Manufacturing Make Sense?2/1/2024
This overview article takes a look at each product development stage for bio/pharmaceuticals to illuminate when continuous manufacturing can satisfy important business drivers.
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Relational Risk Analysis For The Bio/Pharma Industry1/29/2024
Successfully developing and manufacturing biopharmaceuticals depends on identifying, analyzing, and managing a wide variety of risks. This article presents a novel alternative risk analysis approach that provides a simple, easy, and effective method for quickly and efficiently modeling and analyzing any risk.
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FMEA Vs. System Risk Structures (SRS): Which Is More Useful?9/24/2021
In this article, Mark Witcher, Ph.D., discusses the many failure modes of FMEA and risk priority number (RPN), comparing and contrasting it with system risk structures (SRS) and adjusted risk likelihood (RPN). He concludes that one of these is more useful than the other for pharma and medical devices; which one is it?
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Can Biosimilars Be The Bridge To More Widespread Continuous Bioprocessing?5/19/2020
This article will examine the relationship between improved continuous manufacturing (CM) and biosimilar development, paying particular attention to the reasons why biosimilars are especially promising candidates for CM development and innovation.
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Are Good Manufacturing Practices No Longer Good Enough?10/28/2019
Janet Woodcock’s recent comment on the state of pharmaceutical development,“It’s not working…,” should not surprise anyone. Her continuation, “and, it won’t work in the future," is the more surprising, and particularly troubling statement. What must we change?