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.

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.

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.

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

By: Kelly Waldron, Senior Consultant/Business Unit Head, Quality at ValSource

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.

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

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. “ValSource’s brand evolution resulted in a more refined, effective corporate identity and web presence that better communicates the breadth of expertise ValSource represents,” said Whitney Kutney, ValSource vice president. Equipped with a new logo, tagline, mission, and vision, ValSource’s updated brand messaging and detailed expansion of services unifies the corporate team - providing renewed purpose and direction in their efforts to support clients in need of compliance and advisory services. To bring the updated verbal and visual identity to life, a new user-friendly, information-rich website was built with client needs first. Explore the new ValSource website at www.valsource.com. The new identity and website were created and launched by Tayloe/Gray, ValSource’s agency of record. Tayloe/Gray is a full-service digital marketing agency skilled in impactful branding, design, and web development. “It’s been a pleasure to work with Tayloe/Gray throughout the rebranding process. Although our brand is evolving, our commitment to our clients and our employees remains the same. We are looking forward to a fresh start to 2021,” said Kutney.

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.

Diane Blumenthal joins the ValSource board of directors with more than 35 years of experience in biopharmaceutical process and product development, clinical and commercial manufacturing, quality control, scientific facilities, program management, and CMC regulatory. Former SVP/Head of Technical Operations at Spark Therapeutics, Ms. Blumenthal is skilled in building and transitioning companies from a start-up research and development organization to a fully integrated biopharmaceutical company with approved commercial manufacturing operations and products. Throughout her career, Ms. Blumenthal has played a key role in the development and commercialization of several well-known pharmaceutical products.

Katherine Oates brings over 25 years of human resources executive experience to the board of directors at ValSource. Ms. Oates is currently the VP of Human Resources for GlaxoSmithKline’s US Pharmaceuticals business. Throughout Ms. Oates’ career with GSK, she has worked with multiple businesses in a variety of HR leadership roles. Ms. Oates’ primary focus throughout her career has been enhancing organizational effectiveness through talent management, workforce engagement, leadership development, and culture.

Robert Radie joins the ValSource board of directors with three decades of experience working in both public and private pharmaceutical and biotech companies, and across a range of therapeutic areas. Mr. Radie is currently the Chairman of the Board and CEO at Neuraptive Therapeutics, he has also held senior executive positions in six companies, including serving as Chief Executive Officer of Zyla Life Sciences, Inc. Transmolecular Inc, and Topaz Pharmaceuticals, Inc., which was acquired by Sanofi Pasteur. Mr. Radie also currently serves on the board of directors of several companies, including Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK), and Rockwell Medical Technologies Inc. (NASDAQ: RMTI).

The appointment of Ms. Blumenthal, Ms. Oates, and Mr. Radie to the Board of Directors provide the ValSource executive team access to a diverse group of backgrounds, skills, and experience from the life science fields. Our Board of Directors is committed to the success of ValSource. We are excited to leverage their talent and expertise to further our mission.

About ValSource

ValSource is the premier provider of consulting and advisory services for the biological, medical device, and pharmaceutical industries. The company specializes in program and project delivery including capital project execution, procurement, commissioning, qualification and validation, compliance, and quality risk management – serving clients as advisors, trusted consultants, and highly experienced program managers. Valsource is committed to helping projects get to a qualified and validated state with the most efficient solutions. To learn more, visit our website and follow us on LinkedIn and Facebook.

CONTACT: ValSource, Inc Whitney Kutney, Vice President wkutney@valsource.com

Senior Microbiology Consultant Stephen Langille was recently elected to the United States Pharmacopeia’s Compounding Expert Committee for the 2020-2025 cycle. The USP Council of Experts and its Expert Committees are responsible for developing and revising standards for medicines and foods that appear in USP’s compendia, including the United States Pharmacopeia and the National Formulary (USP–NF), which contains quality standards for drug ingredients, drug products, and dietary supplements; the Food Chemicals Codex (FCC); the Dietary Supplements Compendium (DSC); and in other related publications. They also approve USP Reference Standards specified for use in the compendia. Members of the Council of Experts and its Expert Committees develop and review monographs, General Chapters, and testing methods, and collaborate on scientific topics supporting the standards that appear in USP's compendia. Stephen Langille, Ph.D., is a senior microbiology consultant at ValSource, Inc. He specializes in microbiological and particulate matter contamination control. He holds a B.S. degree in biology from the University of Massachusetts and a Ph.D. in microbiology from the University of Maryland. He spent 19 years with the FDA as a microbiology reviewer, branch chief, and director of the Division of Microbiology Assessment in the Center for Drug Evaluation and Research.