ARTICLES BY MARK F. WITCHER

• Managing Contamination Risks In The Pharmaceutical And Medical Device Industries Using Relational Risk Analysis

  2/18/2025

  Of all the risks associated with pharmaceuticals and medical devices, controlling contamination is one of the most important and difficult challenges. Relational risk analysis (ReRA) can help.

• A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices

  2/3/2025

  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.

• System Failure Mode & Effects Analysis (SFMEA): An Alternative Approach For Analyzing Risks

  6/26/2024

  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.

• Managing Supply Chain Risks Using Relational Risk Analysis

  4/5/2024

  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.

• Designing Highly Agile Bio/Pharma Manufacturing Facilities

  4/5/2024

  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. 

• Using Relational Risk Analysis To Control Procedure Failures In The Bio/Pharma & Medical Device Industry

  2/15/2024

  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).

• 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.

• Relational Risk Analysis For The Bio/Pharma Industry

  1/29/2024

  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.

• 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?

• Why Controlling CQAs Isn't Good Enough For Gene & Cell Therapies

  3/31/2020

  It's frequently stated in the biopharma industry that to control a product’s critical quality attributes (CQAs) one must control the process’ critical process parameters (CPPs). While the statement is accurate literally, it does not convey the true technical requirements for controlling product quality.

• 3 Keys To Realizing FDA's Vision For CAR-T And Other ATMPs

  12/12/2019

  While cell therapy remains a very promising approach to developing much-needed new immunotherapies, significant challenges will have to be overcome in order to realize the FDA’s twenty-first century vision of making complex ATMPs widely and cost effectively available to patients.

• Developing And Manufacturing Cell & Gene Therapies: Do Biopharma Methods Apply?

  9/3/2019

  Are the methods used for developing the current generation of biopharmaceuticals, monoclonal antibodies, hormone replacements, etc., applicable to the next generation of Cellular and gene therapies?