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Resource Center

ValSource Viewpoints

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.

ValSource Viewpoints

Annex 1

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

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/

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Annex 1

Annex 1 & PDA Meetings with Hal Baseman, Amanda McFarland, & Ryan Murray

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/

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Annex 1

Annex 1 & FDA with Steve Langille, Jessica Chiaruttini, and Christine Craig

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

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Annex 1

It’s Here! Launching Annex 1 with Kelly Waldron, Ryan Murray, Amanda McFarland, & Hal Baseman

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/

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Annex 1

Revisions to Annex 1: Why? with ValSource’s Jim Vesper & Hal Baseman

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/

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ATMP

Reflections from the PDA ATMP/CGT October 2021 Conference

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.

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ATMP

ATMP/CGT Contamination Control Strategies

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

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ATMP

ATMPs Third Parties

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

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ATMP

On ATMPs: Regulations and Expectations

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

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ATMP

On ATMPs: Phase Appropriate Quality Systems

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

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Annex 1 revision experts.

Our consultants are highly-recognized for their Annex 1 knowledge and expertise. We provide a plan forward through Annex 1 updates, today and into the future.