ValSource

ValSource Viewpoints

Science EN ↓ 34 episodes

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.

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ValSource

Episodes

ATMPs: Regulations and Expectations 09.11.2022 31:44

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

ATMPs: Phase Appropriate Quality Systems 02.11.2022 33:07

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.

ATMPs: Cell & Gene Therapies Series Introduction with Jim Vesper 26.10.2022 14:55

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

The Role of Training in Annex 1 with James Wamsley 19.10.2022 33:04

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

The Role of QRM in Annex 1 with Kelly Waldron, Tiff Baker, & Amanda McFarland 12.10.2022 33:04

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

Annex 1 & PDA Meetings with Hal Baseman, Amanda McFarland, & Ryan Murray 05.10.2022 25:47

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...

Annex 1 & FDA with Steve Langille, Jessica Chiaruttini, & Christine Craig 28.09.2022 33:04

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-roadm...

It's Here! Launching Annex 1 with Kelly Waldron, Ryan Murray, Amanda McFarland, & Hal Baseman 21.09.2022 38:52

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...

Revisions to Annex 1: Why? with ValSource's Jim Vesper & Hal Baseman 14.09.2022 33:04

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 processin...