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

ValSource is proud to announce Senior Consultant Tiffany Baker has been awarded the PDA James Agalloco Award, which honors her outstanding performance in education as a PDA Training and Research Institute (TRI) instructor.

This article was coauthored by ValSource Director of Learning Solutions James Vesper, PhD.

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.

Senior Consultant Darius Pillsbury co-authored this document.

“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 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.

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 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.

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 Michael J. Sadowski and Stephen E. Langille

Read our recent publication in the PDA – Parenteral Drug Association Journal of Pharmaceutical Science & Technology — “Parametric Release of Moist Heat Sterilized Products: History and Current State,” authored by Mike Sadowski, Lead Scientist, Sterility Assurance at Baxter Healthcare Corporation and Stephen Langille, Senior Microbiology Consultant at ValSource Inc.

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

This article presents the first four steps of an initial evaluation roadmap for modern microbial methods. These steps comprise the initial technology assessment, data and compliance risk, cost considerations and an overall instrument evaluation.

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

By ValSource’s Marc Glogovsky & Paula Peacos

PDA Technical Report No. 88, written by ValSource’s Marc Glogovsky & Paula Peacos, along with other industry experts, presents a holistic approach for performing a microbiological investigation. It provides a framework to assist with focusing on the investigational areas that may contain or contribute to the root cause of data deviations, such as sampling, test methodology, and suitability of the test, as opposed to providing methods for analysis of batch acceptability.

The distinct areas where microbial data is collected and inspected for deviation investigations are the focus of this document, including:

1) Roles and responsibilities of personnel, especially microbiologists, in the laboratory investigations and cross-functional teams responsible for manufacturing investigations,

2) Conducting laboratory investigations, and

3) Conducting manufacturing investigations.

The roles of other contributors to deviation investigations required for effective root cause analysis, such as representatives from manufacturing, process engineering, and quality assurance, are also briefly described.

This technical report promotes a lifecycle approach, but greater emphasis is placed on laboratory and manufacturing investigations of marketed drug products.

Full Technical Report available for download by February 13, 2022.

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.

By John Weisgerber, ValSource Senior Project Manager

At ValSource, we only use certified labs to calibrate our test standards, adhering to NIST traceable standards. John Weisgerber, ValSource Senior Project Manager, outlines the key advantages of using an accredited lab for equipment calibration.

This is the 4th episode in our series focused on Advanced Therapeutic Medical Products (ATMPs) that includes cell and gene therapies. Specifically, we’ll be discussing ATMP/CGT and working with third parties. Providing their knowledge are 3 ValSource colleagues who have a wealth of experience: Ryan Murray, Steven Langille, and Darius Pillsbury.

You may select three officers and three board members who will take seats on the PDA Board of Directors. Vote soon, the election runs from Sept 7 – Nov 15. Vote for ValSource Senior Microbiology Consultant Marc Glogovsky for PDA Board of Directors!

By: Steve Langille

By Krunal Patel, ValSource Validation Consultant

The way we work has changed post-pandemic. With remote work and services on the rise, our team is beginning to assess the importance of electronic execution in CQV projects to plan for efficient delivery in the future. Krunal Patel, ValSource Validation Consultant, is applying lessons learned and current pain points to contribute toward development of a process that allows for electronic execution on CQV projects.

ValSource, Inc, a consulting and advisory service provider for the regulated biological, medical device, and pharmaceutical industries, today proudly announced the hire of Jessica Chiaruttini, Ph.D. Jessica’s extensive FDA experience and diverse skill set brings added value to ValSource’s growing team of talent.

ValSource, Inc, a consulting and advisory service provider for the regulated biological, medical device, and pharmaceutical industries, today announced the hire of Beth Fulton, MS as a consultant. Beth’s experience and diverse skill set brings added value to ValSource’s growing team of talent. Kelly Waldron, Quality Business Unit Manager, noted, “Beth is a welcome addition to our team of quality consultants. Her quality and compliance mindset and keen risk-based thinking will ensure we continue to exceed the expectations of our clients.”

ValSource, Inc, a consulting and advisory service provider for the regulated biological, medical device, and pharmaceutical industries, today announced a new Calibration Metrology Group. The new ValSource team not only provides standard calibration services but solves overlaps in instrument validation and calibration processes by providing both services in one.

ValSource, Inc, a consulting and advisory service provider for the regulated biological, medical device, and pharmaceutical industries, today announced the hire of Virginia Andreotti-Jones as a consultant. Virginia’s experience and diverse skill set brings added value to ValSource’s growing team of talent.

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.”

ValSource, Inc, a consulting and advisory service provider for the regulated biological, medical device, and pharmaceutical industries, today proudly announced Tiffany Baker, MBA, Consultant, ValSource Inc, is scheduled to speak at the 2021 PDA Remote Audits & Inspections Workshop on April 8, 2021.

ValSource, Inc, a consulting and advisory service provider for the regulated biological, medical device, and pharmaceutical industries, today announced the hire of Angelica Welch as a consultant. Angie’s experience and diverse skill set brings added value to ValSource’s growing team of talent.

ValSource, Inc, a consulting and advisory service provider for the regulated biological, medical device, and pharmaceutical industries, today proudly announced several members of its Senior Consulting leadership team were recognized by the Parenteral Drug Association (PDA) for their achievements and contributions to the PDA and the healthcare product industry. These awards will be presented at the 2021 PDA Annual Meeting on Advancing People, Connecting Data, and Evolving Manufacturing Technologies, at the 2021 Award Ceremony on March 24, 2021.

Stephen E. Langille, Ph.D., Senior Microbiology Consultant at ValSource, Tiffany Baker, MBA, Consultant at ValSource, Amanda McFarland, MS, Senior Consultant at ValSource, Danica Brown, Consultant at ValSource, and Christopher J. Smalley, MBA, MS, Ph.D., Compounding Pharmacist Advisor at Valsource are each scheduled to speak at the conference at sessions that include Improving, Modernizing, Transforming – Process Validation Gets a (much needed) Upgrade and Modern Toolkits for Enhancing People Competency, Improving Data Integrity through Culture Metrics.

Principles of Parenteral Solution Validation, A Practical Lifecycle Approach – edited by Igor Gorsky and Harold S. Baseman – is part of the Expertise in Pharmaceutical Process Technology series published by Academic Press (Elsevier) and edited by Michael Levin. This book is a comprehensive review of the sequence of activities leading to the current practice of sterile product validation, including example data and case studies.

DOWNINGTOWN, Pa. (Jan. 4, 2020) — ValSource, Inc, a consulting and advisory service provider for the regulated biological, medical device, and pharmaceutical industries, today announced a new corporate
identity, including logo redesign and messaging refinement, as well as the launch of a new website. The refreshed brand and digital presence complement ValSource’s legacy as pioneers in the regulated industry
while providing current and future clients a complete overview of core services and processes.

Good, robust aseptic technique is critical to achieving successful contamination control during manufacture of aseptically processed products. Proper execution of aseptic technique is a skill that requires detailed, in-depth, targeted training, and demonstrated proficiency.

Microbial data deviation investigations (MDDIs) are notoriously difficult to perform. They are time-consuming and labor-intensive. For even the most experienced microbiologists, determining the definitive root cause is often challenging. In most cases, the microbiologist is investigating a past event — sometimes by as much as a week or two. Evidence to support conclusions and decisions takes time to collect, and the available evidence is usually circumstantial and often scanty. Direct evidence (i.e., the “smoking gun”) is rare.

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.

A contamination control program is like a puzzle. Each individual component, such as those mentioned above, represents a single piece of the puzzle. These pieces must fit together to form a whole in order to achieve the desired result.

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.

DOWNINGTOWN, Pa. (Nov. 16, 2020) — ValSource, Inc, a consulting and advisory service provider for the regulated biological, medical device, and pharmaceutical industries, today announced the addition of three new directors to the corporate board. The new ValSource directors include Diane Blumenthal, Katherine Oates, and Robert Radie, each bringing a diverse skill set to the leadership team.

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.

In this article for Pharmaceutical Online, ValSource Principal Consultants Melissa Stappen and Stephen Langille discuss the amount of environmental control, environmental monitoring, and finished product testing necessary to ensure medicinal product microbiological safety and product quality.

Senior Microbiology Consultant Stephen Langille was recently elected to the United States Pharmacopeia’s Compounding Expert Committee for the 2020-2025 cycle. (USP). The role of this Expert Committee is to develop new and revise existing general chapters related to physical analysis (e.g., particles, powders, rheology).