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Resource Center

Publications & Industry News

Forward Thinking: Read the latest in industry breakthroughs.

Recent Insights

Don’t Let a Mistake Go to Waste: Applying Lessons Learned from SpaceX

By Jim Vesper, PhD, Director of Learning Solutions.

The idea of learning from experiences (including failures) can be viewed through the lens of knowledge management, a topic of high interest these days in pharma and biopharma.

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ValSource awarded Hirewire’s prestigious Gold Safety Award

ValSource is proud to receive the Gold Safety Award for Quality Assurance from Highwire. This prestigious award is presented to companies registering a safety score of 85-94% in Hirewire’s Independent Safety Assessment Program, which reviews a company’s historic and current safety performance. The program provides a thorough, objective, and consistent evaluation of company performance so clients and contractors can identify, monitor, and mitigate risks more effectively. The results provide a strong indicator of how a contractor values
safety and serve as a reliable predictor of future performance.

Process Validation in Manufacturing of Biopharmaceuticals, 4th Edition

In the recently published, “Process Validation in Manufacturing of Biopharmaceuticals, 4th Edition,” ValSource Senior Consultants Tiffany Baker and Patrick Mains co-authored a chapter titled, “Principles of Quality Risk Management for Validation.” The book was co-edited by ValSource COO Hal Baseman.

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ISPE 3rd Edition of the Biopharmaceutical Manufacturing Facilities Baseline Guide

ValSource Business Unit Manager Kelly Waldron, PhD, was a lead author of the Quality Risk Management (QRM) Chapter in this publication.

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Best Practices For Use Of Risk Registers In Bio/Pharmaceutical Manufacturing Operations

By ValSource Business Unit Manager Kelly Waldron, PhD; and Senior Consultant Patrick Mains; and Consultant Beth Fulton.

This article highlights some best practices for the use of risk registers in pharmaceutical manufacturing.

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Risk Tool Selection With ICH Q9(R1) In Mind

By ValSource Senior Consultants Amanda McFarland and Ryan Murray

This article published in Outsourced Pharma discusses ICH Q9R1 Quality Risk Management regarding the topic of formality and the role of uncertainty in risk tool selection.

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Assessing the Risk of a Clinically Significant Infection from a Microneedle Array Patch (MAP) Product

By Christine Craig, ValSource Consultant (co-author)

A recently published paper titled, “Assessing the risk of a clinically significant infection from a microneedle array patch (MAP) product,” co-authored by ValSource Consultant Christine Craig, identifies some of the key product and patient-specific factors that may contribute to the risk of infection from a MAP product and provides expert opinions in the context of guidance from regulatory authorities.

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Annex 1 revision experts.

Our consultants are highly-recognized for their Annex 1 knowledge and expertise. We provide a plan forward through Annex 1 updates, today and into the future.