Tune in to our podcast as ValSource experts explore the latest developments and insights within pharmaceutical, advanced therapy medicinal products, biologics and medical device regulated industries.
In this episode, Senior Consultants Amanda Bishop McFarland and Danica Brown discuss the PDA – Parenteral Drug Association/ANSI Standard 03-2025, exploring its development, methodology, and practical application in contamination control and aseptic processing.
In this episode, Senior Consultant and host Amanda McFarland is joined by two experts, Liz Brockson, MPH-VPH, Aseptic Processing and Sterility Assurance Lead at Takeda, and James Wamsley, Senior Consultant at ValSource Inc., to discuss the evolution of contamination control strategies and what it takes to strengthen CCS across today’s regulatory landscape.
In this episode, Senior Consultant and host Amanda McFarland is joined by ValSource colleagues from our consulting team Susannah Davis, Darius Pillsbury, and Erika Pfeiler to discuss how quality leaders can make risk-based decisions, prioritize critical needs, and maintain product quality and patient safety when resources are limited.
This podcast episode features ValSource CEO Whitney Kutney and special guest Karin von Hodenberg, Vice President of Quality at Monte Rosa Therapeutics. In celebration of Women in Engineering Day, these accomplished female leaders share the career journeys that led to their current roles, and discuss the evolving role of women in the engineering and life sciences industry.
In this podcast, discover how AI is reshaping workplace safety, risk management, and leadership decision-making, and learn why human expertise remains essential. Host and ValSource Senior Consultant Amanda McFarland is joined by ValSource Safety Director Patrick Monahan, Fisher Philips Partner Phillip Bauknight, and Haugland Group Environmental, Health, and Safety Manager Jaqueline Handy.
In this podcast, host and ValSource Senior Consultant Amanda McFarland speaks with Business Unit Manager Kelly Waldron and special guest Peter Baker, President of Live Oak Quality Assurance, on data integrity in regulated manufacturing environments and practical ways to make it sustainable.
In this podcast, host and Senior Consultant Amanda McFarland is joined by Senior Consultants Jon Williams, Patrick Mains, Philip Villari, Ryan Murray, Steve Langille, and special guest Tita Tavares, Head of Strategic Marketing and Communications at PDA, to share highlights and reflections from PDA Week.
In recognition of International Women’s Day and Women in Construction Week, ValSource Senior Consultant Amanda McFarland interviewed Hanna M., Head of Quality and Regulatory Compliance at Takeda, and Dr. Gretchen Gagel, PhD, Founder and CEO of the International Institute for Women in Construction. In this podcast, these inspiring industry leaders share their insights and experiences on advancing women’s voices and impact.
In this episode, ValSource Senior Consultant Amanda McFarland talks with VP, Business Development Brian Jordan, Safety Director Patrick Monahan, and special guest John Moehnke, COO of partner company PIMSHQ, about the 2026 Construction Users Roundtable (CURT) National Conference.
In this episode, Senior Consultant Amanda McFarland speaks with ValSource Consultant Virginia Andreotti-Jones and GMP Services Principal Consultant Valerie Mulholland about often overlooked factors that shape quality risk decisions in regulated environments.
In this episode, Director of Learning and Training Jim Vesper, PhD, speaks with Validation Project Manager Matt Hausman, Consultant Christine Craig, and Senior HR & Benefits Administrator Kristen Gallagher about the unique organizational culture at ValSource. Tune in to learn why these team members joined ValSource and hear what their favorite aspects of working here have been.
In this episode, ValSource Business Unit Manager Kelly Waldron, PhD, interviews Director of Learning Jim Vesper, PhD, and Senior Consultant Amanda McFarland about their recent publication, ”Quality Risk Management – A Practical Guide.”
In this episode, Director of Learning Solutions Jim Vesper speaks with Senior Consultant Patrick Mains about his experience at a recent conference on AI in Biopharma Manufacturing.
Get to know some of our employees in a new podcast series, “Working at ValSource.”
In the first episode, Director of Learning and Training Jim Vesper, PhD, speaks with Validation Engineers Connor Welts, Taylor Ouellette (Wood), Tyler Johnson, Justin Pace, Austin Carter, and CQV Engineers James Do and Raegan Patterson. Tune in to learn what brought them to ValSource and hear what their experiences have been like so far.
In this episode, ValSource Director of Learning Jim Vesper, PhD, speaks with Director of Metrology & Calibration Andrew Hooper about ValSource’s Metrology & Calibration Services.
In this episode, ValSource Director of Learning Solutions Jim Vesper, PhD, speaks with EPREX Director John Molaskey. Tune in to learn more about how ValSource’s women-owned equipment/services procurement and expediting partner can help with cost savings and efficiency.
ValSource Director of Learning Solutions Jim Vesper, PhD, and Senior Consultant Fred Ayers discuss this year’s PDA Pharmaceutical Microbiology Conference.
In this podcast, ValSource Director of Learning and Training Jim Vesper, PhD speaks with Business Unit Manager Kelly Waldron, PhD and Consultant Heather Hafer-DeMilto about their experiences at the 2024 PDA/FDA Regulatory Conference.
In this episode, ValSource Director of Learning James Vesper, PhD, speaks with Regional Manager John Sorrentino about the importance of Piping & Instrumentation Diagrams (P&IDs) in the pharmaceutical and biopharma industries.
Part Three of ValSource Viewpoint’s special safety-focused podcast series. In this episode, Director of Learning Jim Vesper, PhD, speaks with Senior Safety Consultant Art Limper and partner technology company PIMSHQ’s COO John Moehnke about a safety solutions success case.
Part two of a special safety-focused podcast series. In this episode, Director of Learning, Jim Vesper, PhD, talks with John Moehnke from our partner software company, PIMSHQ, about the important role that technology plays in supporting an effective safety program.
This episode is part one of a safety-focused series. ValSource Senior Safety Consultant Art Limper, known for his career enhancing safety protocols and promoting best practices across all aspects of pharmaceutical manufacturing and operations, discusses what it takes to create a successful safety program. Limper has been a key contributor to ValSource Safety Solutions, a comprehensive program combining ValSource consulting services and resources with PIMSHQ’s innovative PIMS Safety software.
In this episode, ValSource Director of Learning Jim Vesper, PhD, and Senior Consultant Amanda McFarland, join PDA Chief of Staff Tita Tavares to discuss their reflections on the 2024 PDA Annual Meeting. Topics covered include new additions to the format, favorite sessions, and the overarching theme of innovation.
In this podcast, Jim Vesper speaks with four ValSource Consultants who have been presenting at or attending Annex 1 workshops across the U.S., Europe and Asia. Tune in for insights from industry experts Amanda McFarland, Fred Ayers, Kim Sobien and James Wamsley.
This is the 5th episode in our series focused on Advanced Therapeutic Medical Products (ATMPs) that include cell and gene therapies. Specifically, we’ll be discussing ATMP/CGT and Contamination Control strategies. You can tune into ValSource Viewpoints on Spotify, Apple Podcasts, & Google Podcasts.
Learn about how ValSource can support your Annex 1 planning: https://valsource.com/annex1-gap-analysis/
In the 4th episode in our series focused on Advanced Therapeutic Medical Products (ATMPs) that include cell and gene therapies, we’ll be discussing ATMP/CGT and working with third parties. You can tune into ValSource Viewpoints on Spotify, Apple Podcasts, & Google Podcasts.
Learn about how ValSource can support your Annex 1 planning: https://valsource.com/annex1-gap-analysis/
Continue the ATMP discussion with our experts. This episode is focused on working with third parties, what regulations and expectations are out there now, and what might be coming around the corner. You can tune into ValSource Viewpoints on Spotify, Apple Podcasts, & Google Podcasts.
Learn about how ValSource can support your Annex 1 planning: https://valsource.com/annex1-gap-analysis/
Listen & Learn – ValSource experts explore Phase Appropriate GMPs as they apply to Advanced Therapeutic Medical Products or ATMPs. You can tune into ValSource Viewpoints on Spotify, Apple Podcasts, & Google Podcasts.
Learn about how ValSource can support your Annex 1 planning: https://valsource.com/annex1-gap-analysis/
Meet the Experts! The first episode in the Advanced Therapeutic Medicinal Products or ATMPs series, including Cell & Gene Therapies.
You can tune into ValSource Viewpoints on Spotify, Apple Podcasts, & Google Podcasts. Learn more about how ValSource can support your Annex 1 planning: https://valsource.com/annex1-gap-analysis/
Important Announcement — The International Council for Harmonization (ICH) issued a revision of the Q9 guideline for risk management. ValSource consultants specialize in risk management. Tune into our new podcast to hear from three of them — Amanda McFarland, M.Sc. Senior Consultant, Beth Fulton, M.S. QRM Consultant, and Patrick Mains, PMP, Senior Consultant as they discuss significant changes that are in the R1 version of Q9.
In this podcast Jim Vesper is talking with two ValSource experts involved with airflow visualization studies – otherwise known as “Smoke Studies”. Two colleagues are Walter Henkels and James Walmsley.
Tune in to our newest Annex 1 podcast episode, The Role of Training in Annex 1. In this podcast, host Jim Vesper talks with one of our ValSource consultants who has a strong background in training, James Wamsley.
You can tune into ValSource Viewpoints on Spotify, Apple Podcasts, & Google Podcasts. Learn more about how ValSource can support your Annex 1 planning: https://valsource.com/annex1-gap-analysis/
Continue listening to our newest podcast series on Annex 1! In this episode, host Jim Vesper and experts discuss The Role of QRM in Annex 1. Featured speakers include ValSource senior consultants Kelly Waldron, Tiff Baker, and Amanda McFarland.
You can tune into ValSource Viewpoints on Spotify, Apple Podcasts, & Google Podcasts. Learn more about how ValSource can support your Annex 1 planning: https://valsource.com/annex1-gap-analysis/
Tune in to our new podcast episode — Annex 1 & PDA Meetings. In this podcast, we’re talking with several ValSource consultants who have been involved in two PDA workshops on Annex 1. This first workshop was held in Dallas following the PDA’s annual meeting the first week of April with the second one in Dublin in May. Featured speakers include host Jim Vesper, director of Learning Solutions at ValSource, Ryan Murray, ValSource Consultant, Amanda McFarland, ValSource Senior QRM and Microbiology Consultant and Hal Baseman, a recognized industry expert on aseptic processing and a principal at ValSource.
You can tune into ValSource Viewpoints on Spotify, Apple Podcasts, & Google Podcasts. Learn more about how ValSource can support your Annex 1 planning: https://valsource.com/annex1-gap-analysis/
In this podcast, host Jim Vesper talks with three ValSource consultants who all have had experience working at US FDA and are microbiologists by training — Steve Langille, Jessica Chiaruttini, and Christine Craig.
You can tune into ValSource Viewpoints on Spotify, Apple Podcasts, & Google Podcasts. Learn more about how ValSource can support your #Annex1 planning: https://valsource.com/annex1-roadmap-guide-to-success
Listen to the second episode of our Annex 1 podcast series on Launching Annex 1. Featured speakers include host Jim Vesper, director of Learning Solutions at ValSource, Kelly Waldron Ph.D. ValSource Business Unit Manager – Quality and Manufacturing Science, Ryan Murray, ValSource Consultant, Amanda McFarland, ValSource Senior QRM and Microbiology Consultant, and Hal Baseman, a recognized industry expert on aseptic processing and a principal at ValSource.
Listen to ValSource Viewpoints on Spotify, Apple Music, & Google Podcasts. Learn more about how ValSource can support your Annex 1 planning at https://valsource.com/annex1-roadmap-guide-to-success/
ValSource Viewpoints is back with a new Annex 1 #podcast series! Listen to the first episode in the series concerning the revision to Annex 1, which is the European Medicine Agency’s requirements for producing sterile medicinal products. Featured ValSource team members include Jim Vesper, director of Learning Solutions at ValSource, and Hal Baseman, a recognized industry expert on aseptic processing and a principal at ValSource.
Listen to ValSource Viewpoints on Spotify, Apple Music, & Google Podcasts. Learn more about how ValSource can support your Annex 1 planning at https://valsource.com/annex1-roadmap-guide-to-success/
Continue listening to our podcast series focused on Advanced Therapeutic Medical Products (ATMPs), including cell and gene therapies. Today’s topic is a look-back at the October 2021 ATMP/CGT meeting hosted by the PDA – Parenteral Drug Association – with our panel of experts Darius Pillsbury, Kelly Waldron, PhD, and Virginia Andreotti-Jones.
This is the 5th episode in our series focused on Advanced Therapeutic Medical Products (ATMPs) that include cell and gene therapies. Specifically, we’ll be discussing ATMP/CGT and Contamination Control strategies.
You can tune into ValSource Viewpoints on Spotify, Apple Podcasts, & Google Podcasts. To learn more about how ValSource can support you, visit www.valsource.com
In the 4th episode in our series focused on Advanced Therapeutic Medical Products (ATMPs) that include cell and gene therapies, we’ll be discussing ATMP/CGT and working with third parties.
You can tune into ValSource Viewpoints on Spotify, Apple Podcasts, & Google Podcasts. To learn more about how ValSource can support you, visit www.valsource.com
Continue the ATMP discussion with our experts. This episode is focused on working with third parties, what regulations and expectations are out there now, and what might be coming around the corner.
You can tune into ValSource Viewpoints on Spotify, Apple Podcasts, & Google Podcasts. To learn more about how ValSource can support you, visit www.valsource.com
Listen & Learn – ValSource experts explore Phase Appropriate GMPs as they apply to Advanced Therapeutic Medical Products or ATMPs.
You can tune into ValSource Viewpoints on Spotify, Apple Podcasts, & Google Podcasts. To learn more about how ValSource can support you, visit www.valsource.com
Meet the Experts! The first episode in the Advanced Therapeutic Medicinal Products or ATMPs series, including Cell & Gene Therapies.
You can tune into ValSource Viewpoints on Spotify, Apple Podcasts, & Google Podcasts. To learn more about how ValSource can support you, visit www.valsource.com
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