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Resource Center

Valid Insights

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Recent Insights

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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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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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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How To Become A (Better) Facilitator For Risk Assessment And Root Cause Analysis – James Vesper, Ph.D., MPH and Amanda Bishop McFarland

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.

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Seeking the Golden Mean: Optimizing Your QRM Program – Amanda Bishop McFarland

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

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Quality Risk Management And The Draft Annex 1 Revision — What To Expect – Hal Baseman and Kelly Waldron, Ph.D.

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

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Points to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration

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

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Points to Consider When Doing an Annex 1 Self-Assessment – By Darius Pillsbury and Stephen Langille. December 8, 2020 | 10:30 AM – 12:30 PM | EST

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.

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Environmental Monitoring and Sterility Assurance Control for Medical Devices and Combination Products

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.

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