Shows
ValSource ViewpointsHidden Influences in Quality Risk DecisionsIn 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.
2026-01-2244 minValSource ViewpointsWorking At ValSource - Part 2Get to know some of our employees. In this episode, Director of Learning and Training Jim Vesper, PhD, speaks with Validation Project Manager Matt Hausman, Consultant Christine Craig, and Senior HR and Benefits Administrator Kristen Gallagher, about how they came to work at ValSource and what their experience has been so far.
2025-08-1921 minValSource ViewpointsBook Review: Quality Risk Management – A Practical GuideIn 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.
2025-07-2123 minValSource ViewpointsAI in Biopharma ManufacturingIn this episode, Director of Learning Solutions Jim Vesper, PhD, speaks with Senior Consultant Patrick Mains about his experience at a recent conference on AI in Biopharma Manufacturing. Tune in to learn how AI and Machine Learning are impacting this industry, and hear some predictions for the future of these exciting technologies.
2025-05-1921 minValSource ViewpointsWorking at ValSourceGet to know some of our employees. In this 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 about how they came to work at ValSource and what their experience has been so far.
2025-03-0429 minValSource ViewpointsMetrology & Calibration ServicesIn this episode, ValSource Director of Learning Jim Vesper, PhD, speaks with Director of Metrology & Calibration Andrew Hooper about ValSource’s Metrology & Calibration Services.
2025-02-0623 minValSource ViewpointsIntroducing EPREX - ValSource's Equipment/Services, Procurement and Expediting partnerValSource Director of Learning Solutions Jim Vesper, PhD, speaks with EPREX Director John Molaskey. Tune in to learn more about how our women-owned equipment/services procurement and expediting partner can help with cost savings and efficiency.
2024-11-2122 minValSource ViewpointsReflections on the 2024 PDA Pharmaceutical Microbiology ConferenceValSource Director of Learning Solutions Jim Vesper, PhD, and Senior Consultant Fred Ayers discuss this year's PDA Pharmaceutical Microbiology Conference.
2024-11-1416 minValSource ViewpointsReflections on the 2024 PDA/FDA Regulatory ConferenceIn 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 experience at the 2024 PDA/FDA Regulatory Conference.
2024-10-1514 minValSource ViewpointsThe importance of Piping & Instrumentation Diagrams (P&IDs)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.
2024-09-2725 minValSource ViewpointsA Safety Solutions Success CasePart 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.
2024-08-1632 minValSource ViewpointsLeveraging Technology for a More Successful Safety ProgramIn 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.
2024-07-0911 minValSource ViewpointsBuilding an Effective and Engaged Safety Culture in the Construction IndustryThis episode is the first of a new 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.
Art 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.
2024-06-2617 minValSource ViewpointsReflections on the 2024 PDA Annual MeetingValSource 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.
2024-05-1615 minValSource ViewpointsWhat's been happening with Annex 1?Insights and observations from four ValSource Consultants who have been presenting at or attending Annex 1 workshops across the U.S., Europe and Asia.
2024-03-0527 min
Legacy Listens46. Exit Interview - Transitioning with Integrity: A Founder's Path to ESOP and Legacy ft. Dave CalvaresiJoin host Kevin Donohue on Legacy Listens as he explores the entrepreneurial journey with David Calvaresi, Founder of ValSource who is heavily committed to the community, one institution he works with is a nonprofit by the name of Headstrong. Follow Dave's compelling story—from starting a business amidst family challenges to building a thriving workforce. Learn how he navigated financial crises, maintained a strong company culture, and implemented an ESOP for employee ownership. In this candid conversation, discover insights on resilience, preserving culture, and graceful business exits. Tune in for lessons from a leader dedicated to both business success an...
2024-02-2638 minValSource ViewpointsUpdates to ICH Q9 R1: Quality Risk Management GuidelinesImportant 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.
2023-02-2318 minValSource ViewpointsAnnex 1 Series – Airflow Visualization StudiesIn 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.
2022-11-3022 minValSource ViewpointsATMP/CGT Contamination Control StrategiesThis 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
2022-11-2316 minValSource ViewpointsATMPs: Third PartiesIn 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
2022-11-1623 min
Risk RevolutionFrom Dreading the Risk Process to Living the Risk LifeThis episode was originally aired on July 13th, 2021
This week our series coordinators, Lori and Nuala, invite their guest Amanda McFarland to chat about Living the Risk Life. How do we take our colleagues on a journey from dreading their participation in the risk process to actually living a work-life and culture that embraces risk management?
Resources from this episode:
12 Inclusive Behaviors - The Kaleel Jamison Consulting - https://kjcg.com/s/12InclusiveBehaviors_AR_01202015.pdf
How To Become A (Better) Facilitator For Risk Assessment And Root Cause Analysis - https://www.pharmaceuticalonline...
2022-11-1354 minRisk RevolutionFacilitator - Friend or Foe?This episode was orginally aired on June 15th, 2021
In this episode, we discuss the importance of facilitation in the risk management process and how it leads to the success of a risk assessment. Joining in on this conversation is Tiff Baker, Senior Consultant from ValSource.
Resources in this episode:
Humble Inquiry - The Gentle Art of Asking Instead of Telling Building Positive Relationships and Better Organizations, (2021) Edgar Schein
The Surprising Power of Questions HBR
Bias, Heuristics & Risk (Pt. 1) on Risk Revolution | IVT
Bias, Heuristics & Risk (Pt. 2) on Risk...
2022-11-1357 minValSource ViewpointsATMPs: Regulations and ExpectationsContinue 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
2022-11-0931 minValSource ViewpointsATMPs: Phase Appropriate Quality SystemsListen & 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.
2022-11-0233 minValSource ViewpointsATMPs: Cell & Gene Therapies Series Introduction with Jim VesperMeet 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
2022-10-2614 minValSource ViewpointsThe Role of Training in Annex 1 with James WamsleyTune 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
2022-10-1933 minValSource ViewpointsThe Role of QRM in Annex 1 with Kelly Waldron, Tiff Baker, & Amanda McFarlandContinue 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
2022-10-1233 minValSource ViewpointsAnnex 1 & PDA Meetings with Hal Baseman, Amanda McFarland, & Ryan MurrayTune 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.
Learn more about...
2022-10-0525 minValSource ViewpointsAnnex 1 & FDA with Steve Langille, Jessica Chiaruttini, & Christine CraigIn 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
2022-09-2833 minValSource ViewpointsIt's Here! Launching Annex 1 with Kelly Waldron, Ryan Murray, Amanda McFarland, & Hal BasemanListen 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/
2022-09-2138 minValSource ViewpointsRevisions to Annex 1: Why? with ValSource's Jim Vesper & Hal BasemanValSource 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/
2022-09-1433 min
Ambulatory Healthcare TodayChallenges in the Development, Production and Distribution of COVID-19 VaccinesIn this episode, the NextGen Advisors are joined by James Vesper, PhD, MPH, Director of Learning Solutions for ValSource, former President of LearningPlus and an advisor to the World Health Organization to discuss the anticipated distribution of COVID-19 vaccines. During the podcast, Dr. Vesper discusses some of the unique attributes of the vaccines, as well as the challenges that we will face as we get closer to production and distribution.
2020-12-0417 min
The FS Club PodcastUncovering Opportunities: How Finance Executives Can Use Machine Learning To Gain A Leading EdgeFind out more on our website: https://bit.ly/3t1ZW8j
Machine learning is becoming an essential technology, no matter the industry. Data is now the heart and soul of business, and comprehending it effectively is crucial to making decisions. For that reason, financial executives need to insert themselves into the conversation about the right data to use, applying their institutional knowledge while simultaneously understanding key principles of machine learning.
The aim of this webinar is to demystify the use of ML and give finance professionals a way to decide how to use it...
2020-10-2048 min