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.

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.

A recent article titled, “What To Do When Your Regulatory Findings Need Quality Risk Management Action,” written by ValSource Consultants Virginia Andreotti-Jones, Danica Brown, and Heather Hafer-DeMilto was published in Pharmaceutical Online.

An article titled, “Risk- And Science-Based Media and Buffer Mixing Validations,” written by ValSource Senior Consultants Igor Gorsky and Beth Fulton was published in the March/April 2024 issue of Pharmaceutical Engineering.

A recent article titled, “A Novel Approach To Managing Risks In Aseptic Processing Of Cell & Gene Therapies,” written by ValSource Senior Consultants Darius Pillsbury and Tiffany Baker was published in Cell & Gene, Outsourced Pharma, and Bioprocess Online.

This is the first in a series of three articles that will be published.

The following article published in Cell & Gene by ValSource Senior Consultants Amanda McFarland ; Patrick Mains; and Consultant Theo Zacharatos; discusses the importance of having a robust cross contamination program.

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.

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

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.

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.