ValSource Viewpoints: Recent Episodes
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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, ValSource Director of Learning James Vesper, PhD, speaks with Regional ManagerJohn 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.
In Part Two of our special safety-focused podcast series, ValSource Director of Learning Jim Vesper, PhD, talks with PIMSHQ COO John Moehnke about the important role that technology plays in supporting an effective safety program.
This episode is the first of a new safety-focused series.
ValSource Senior Safety Consultant ArtLimper, 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. Art has been a key contributor to ValSource SafetySolutions, a comprehensive program combining ValSource consulting services and resources with PIMSHQ’s innovative PIMS Safety software.
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.
Insights and observations from four ValSource Consultants who have been presenting at or attending Annex 1 workshops across the U.S., Europe and Asia.
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.
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.
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.
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.
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.
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.
To learn more about how ValSource can support you, visit www.valsource.com
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.
Learn more about how ValSource can support your Annex 1 planning at 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 senior consultants Kelly Waldron, Tiff Baker, and Amanda McFarland.
Learn more about how ValSource can support your Annex 1 planning at 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 Play. Learn more about how ValSource can support your Annex 1 planning: https://valsource.com/annex1-roadmap-guide-to-success
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 Play. Learn more about how ValSource can support your Annex 1 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.
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.
Learn more about how ValSource can support your Annex 1 planning at https://valsource.com/annex1-roadmap-guide-to-success/
Meet the Experts! The first episode in the Advanced Therapeutic Medicinal Products or ATMPs series, including Cell & Gene Therapies.