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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.Read Article
ValSource Business Unit Manager Kelly Waldron, PhD, was a lead author of the Quality Risk Management (QRM) Chapter in this publication.Read Article
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.Read Article
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.Read Article
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.Read Article
By ValSource Consultants Beth Fulton and Angelica Welch
A recent article by ValSource Consultants Beth Fulton and Angelica Welch published in the PDA Journal of Pharmaceutical Science and Technology outlines a risk-based approach for navigating remediation (non-routine sanitization) of contaminated affinity-based resins.Read Article
By ValSource Director of Learning James Vesper, PhD, MPH and Senior Consultant Amanda McFarland, MSC
A recent article by ValSource Director of Learning Solutions James Vesper and Senior Consultant Amanda McFarland published in Pharmaceutical Technology discusses how using the four-phased “Kirkpatrick Model” method in evaluating a QRM can ensure continual improvement and that regulatory requirements are met.Read Article
By Danica Brown and Theo Zacharatos, ValSource Inc.
Check out part 2 of the ICH Q9(R1) article series from ValSource colleagues, Danica Brown and Theo Zacharatos. Get detailed insight on subjectivity and product availability risks.Read Article
By Stacey Largent, M. Eng. and Virginia Andreotti-Jones, ValSource Inc.
The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.Read Article
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