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Publications & Industry News

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Recent Insights

ValSource Consultant Scheduled To Speak 2021 PDA Workshop

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.

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ValSource Announces New Hire Angelica Welch

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.

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ValSource Leadership Awarded at 2021 PDA Annual Meeting

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.

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ValSource Technical Leadership to Speak at 2021 PDA Annual Meeting

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.

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Available Now – Principles of Parenteral Solution Validation by Igor Gorsky and Harold S. Baseman

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.

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ValSource Announces New Website and Brand

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.

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Training Production Operators In Aseptic Technique: Common Pitfalls & How to Avoid Them – Paula Peacos

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.

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Essential Points To Consider For Better Microbial Data Deviation Investigations – Paula Peacos

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.

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Quality Risk Management 101: ICH Q9 In Context – Kelly Waldron, Ph.D.

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.

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Contamination Control Programs and the Microbiologist – The Changing Landscape – Paula Peacos & Marc Glogovsky, MS, S.M. (NRCM)

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.

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