This article was co-authored by Business Unit Manager Kelly Waldron, PhD, and Senior Consultant Igor Gorsky.

By Igor Gorsky, Senior Consultant.

A process validation specialist from the ValSource QRM team shares additional insights on where the state of the guidance is headed for this industry.

This article was coauthored by ValSource Business Unit Manager Kelly Waldron, Senior Consultant Amanda McFarland, and VP Hal Baseman. Maik Jornitz is also a contributing author.

By Igor Gorsky, Senior Consultant.

A process validation expert from the ValSource QRM team shares his insights on where the state of the guidance is headed for this industry.

“Quality Risk Management – A Practical Guide,” written by ValSource Director, Learning Solutions James Vesper and Senior Consultant Amanda McFarland is now available in the PDA Bookstore.

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.

By Tiff Baker, Senior Consultant.

An experienced QRM Practitioner discusses her observations from recent projects and shares important lessons learned to help improve the future of this industry.

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.

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.

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.

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.

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.

By Tiffany Baker, Danica Brown, and Amanda McFarland; ValSource, Inc.

Dive into common risk management pain points and discover mechanisms to overcome these challenges, focusing on the foundation of quality risk management (QRM). Read our recent publication in Outsourced Pharma by ValSource team members: Tiffany Baker, Danica Brown, and Amanda McFarland.

By Ryan Murray, M.Sc., and Amanda McFarland, M.Sc., ValSource, Inc.

Read our recent publication with Outsourced Pharma — “CDMOs And Contamination Control Strategy: The Span Of Oversight In EU GMP Annex 1 Compliance,” authored by ValSource team members Ryan Murray, Senior Consultant & Amanda Bishop McFarland.

By Ryan Murray, M.Sc., and Amanda McFarland, M.Sc., ValSource, Inc.

Over the last several years, various revisions of the EU’s Annex 11 have been released and reviewed by countless numbers of subject matter experts across our industry. The final version is now published, and it is time to take action. Read more from Ryan Murray, M.Sc., and Amanda McFarland, M.Sc.

By Jim Vesper, Ph D., ValSource Inc.

As someone who has been involved in risk management for a number of years, it has been interesting during COVID-19 to step back and reflect on some of my recent decisions and actions: Do we host a holiday party for 80 people? How about a smaller event for 30 people who all claim to have been fully vaccinated? Do we go to a restaurant that requires proof of vaccination? What about that gathering with some friends we haven’t seen in nearly two years but haven’t been vaccinated?

The responses to these questions – and many others – are based on how much risk we are willing to accept or reject, or more specifically in the vocabulary of risk management, our risk appetite and risk tolerance.

This article describes and differentiates risk appetite and risk tolerance and discusses why these two concepts are foundational to how we make risk-based decisions.

By Amanda McFarland, M.Sc., Senior Consultant at ValSource, Inc.

Plot A Successful Course: Critical Risk Assessments With CDMOs – Amanda McFarland

Guest Column Article by Tiffany Baker, Danica Brown, and Amanda McFarland of ValSource, Inc.

Guest Column Article by Tiffany Baker, Danica Brown, and Amanda McFarland of ValSource, Inc.

ValSource, Inc, a consulting and advisory service provider for the regulated biological, medical device, and pharmaceutical industries, today proudly announced two leadership team members will lead a live, interactive training webinar hosted by Pharma Webinars, “Are You Ready for Annex 1? Points to Consider When Doing an Annex 1 Self-Assessment.”

This is the third article in a series of six intended to provide a holistic primer on the field of quality risk management (QRM). The first article, Quality Risk Management 101: Risks Associated With Medicinal Products, discussed the difference between intrinsic and extrinsic risks and clarified the scope of QRM efforts and was followed by Quality Risk Management 101: A Brief History Of Risk Management In The Regulation Of Medicinal Products. Future articles will discuss the role of QRM across the product life cycle, primary literature sources for QRM, and common challenges associated with QRM implementation.

When subject matter experts (SMEs), management, and others gather to perform a risk assessment or a root cause analysis on a failure, they’re sure to achieve the desired outcome, right? Perhaps for a simple risk assessment or investigation, but success is not very likely for one that is even moderately complicated. That’s where a skilled facilitator is needed.

If you were tasked with assessing your Quality Risk Management (QRM) program, would you find yourself in the “just right” category?

Part of the ValID Insight series, a timely look at issues and insights shaping the regulated pharmaceutical industry worldwide.

Dr. Kelly Waldron, a Senior Consultant at ValSource, served as lead author of the recently-published PDA/Biophorum Points to Consider entitled Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration. She led a team of experts in sterilizing grade filter manufacture and use through an intensive Quality Risk Management (QRM) exercise designed to enable a complete understanding of potential failures and related causal factors associated with the manufacture of sterilizing grade filters and their use by parental drug manufacturers. The risk assessment outcomes were used to create a sterilizing filtration control strategy aimed at patient protection.

The Points to Consider enables readers to perform a similar assessment using a number of QRM techniques at their own firms, which can improve sterility assurance and enable decisions regarding the inclusion or potential exclusion of commonly debated controls, such as pre-use post-sterilization filter integrity testing (PUPSIT). Dr. Waldron’s team was comprised of experts from over 25 companies, including both filter manufacturers and sterile drug producers, as of the PDA/BioPhorum Sterilizing Filtration Quality Risk Management Consortium. The Points to Consider document is available through PDA at the link below

ValSource senior consultants Darius Pillsbury and Stephen Langille will deliver a 2-hour live training event through Pharma Webinars to discuss this important document.

Led by two experts, this inclusive live webinar will provide attendees with an overview of the history and changes to Annex 1, cover many of the topics necessary to ensure readiness for Annex 1 compliance, and describe the impact of this document on the global regulatory environment. Among the specific topics to be discussed during the webinar will be the development and implementation of a contamination control strategy, risk assessments and quality risk management for sterile products, control of cleanrooms and environmental monitoring, sterile filtration and filter validation, control and use of isolators and RABS for aseptic processing, personnel qualification and behavior in aseptic environments, and aseptic processing simulation requirements.

Following this webinar, attendees will understand the major points of emphasis in Annex 1 with regard to the control of sterile product operations and be able to complete a basic self-assessment to gauge their preparedness for Annex 1 compliance.