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2 months ago | 
outsourcedpharma.com | Mark Witcher |Louis Garguilo
By Mark F. Witcher, Ph.D., biopharma operations subject matter expert
Of all the risks associated with pharmaceuticals and medical devices, controlling contamination is one of the most important and difficult challenges.
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2 months ago | 
outsourcedpharma.com | Mark Witcher |Louis Garguilo
By Mark F. Witcher, Ph.D., biopharma operations subject matter expert
Controlling human errors is one of every organization’s greatest challenges. Human errors account for a majority of failures in executing many complex activities in aviation, nuclear, and many other industries.1 The same is true for biopharmaceuticals and medical devices.
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Dec 7, 2024 | 
meddeviceonline.com | Mark Witcher |Allan Marinelli |Abhijit Menon |Brett Mason
This article puts a new lens on the risk model in Annex C of ISO 14971 using relational risk analysis to describe a better approach for understanding and managing medical device risks. In part 2 of the authors' series on computer systems validation pitfalls, they cover misinterpretations and unnecessary "nice to haves" that waste execution efficiencies.
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Oct 23, 2024 | 
meddeviceonline.com | Mark Witcher
Guest Column
| October 23, 2024
By Mark F. Witcher, Ph.D., biopharma operations subject matter expert
ISO 14971 is one of the most referenced and quoted risk analysis guidance documents in the medical device industry.1 The guidance’s influence sometimes extends well beyond just medical devices.
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Aug 10, 2024 | 
cellandgene.com | Mark Witcher |Q-Specialists AB |Irwin Hirsh |Anthony Stewart
Hello Cell & Gene readers,I'm happy to bring you July's most-clicked articles. Enjoy!Erin Harris, editor-in-chief Follow me on XJULY'S BEST FEATURED EDITORIALSystem Failure Mode & Effects Analysis: Intuitive Risk AnalysisYour 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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Aug 10, 2024 | 
pharmaceuticalonline.com | Tim Sandle |John W.M. Claud |Mark Witcher |Geraldine Carr-Mulry
JULY'S BEST FEATURED EDITORIALChatGPT-4: Practical Applications For The Biopharma LaboratoryAI has made its way into the biopharma laboratory, and ChatGPT-4 is the most popular. Do you know the capabilities that this tech can deliver? Making Good Decisions When FDA Investigators Come KnockingReady or not, when the FDA inspector arrives, the test has already started. New final guidance makes clear what the agency considers an attempt to stonewall.
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Jul 30, 2024 | 
meddeviceonline.com | Mark Witcher |André Ayres Martinez |DSM Biomedical |Jessica Sanford
Your company likely uses risk matrices and Failure Mode & Effects Analysis (FMEA) for analyzing risks. Let's explore an alternative approach for conducting a system failure mode & effects analysis. Membranes Allow For Greater Functionality In Oxygen-Dependent SensorsWearable biosensors have been widely adopted for diabetes management, with the potential for broader applications. Discover how polymer formulations are expanding the reach of this technology.
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Jul 24, 2024 | 
cellandgene.com | Mark Witcher |Kristin N. Heller |Andrew Moreo |Jonathan Rush
Your company likely uses risk matrices and FMEA for analyzing risks. This article describes an alternative approach for conducting a system failure mode and effects analysis. Key Challenges In mRNA ManufacturingManufacturing mRNA products is a complex and challenging process that requires careful consideration at each stage. Learn more about the challenges and intricacies involved.
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Jul 18, 2024 | 
biosimilardevelopment.com | Mark Witcher
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. Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence? Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.
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Jul 3, 2024 | 
outsourcedpharma.com | Louis Garguilo |Mark Witcher |Soudeh F. Tehrani |Lisa Lemelin
The U.S. House Rules Committee did not include the BIOSECURE Act in the final list of amendments for the National Defense Authorization Act (NDAA). Chief Editor Louis Garguilo has been outspoken in defending WuXi Apptec’s right to due process. Readers have responded in spades. Here's the latest.
