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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 & FDA with Steve Langille, Jessica Chiaruttini, and Christine Craig
September 28, 2022

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 #Annex1 planning: https://valsource.com/annex1-roadmap-guide-to-success

It’s Here! Launching Annex 1 with Kelly Waldron, Ryan Murray, Amanda McFarland, & Hal Baseman
September 21, 2022

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 Play. Learn more about how ValSource can support your Annex 1 planning at https://valsource.com/annex1-roadmap-guide-to-success/

Revisions to Annex 1: Why? with ValSource’s Jim Vesper & Hal Baseman
September 14, 2022

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 Play. Learn more about how ValSource can support your Annex 1 planning at https://valsource.com/annex1-roadmap-guide-to-success/

Reflections from the PDA ATMP/CGT October 2021 Conference
December 20, 2021

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.

ATMP/CGT Contamination Control Strategies
November 18, 2021

This is the 5th episode in our series focused on Advanced Therapeutic Medical Products (ATMPs) that includes cell and gene therapies. Specifically, we'll be discussing ATMP/CGT and Contamination Control strategies.

ATMPs Third Parties
October 11, 2021

In the 4th episode in our series focused on Advanced Therapeutic Medical Products (ATMPs) that includes cell and gene therapies, we'll be discussing ATMP/CGT and working with third parties.

On ATMPs: Regulations and Expectations
August 20, 2021

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.

On ATMPs: Phase Appropriate Quality Systems
June 25, 2021

Listen & Learn. ValSource experts explore Phase Appropriate GMPs as they apply to Advanced Therapeutic Medical Products or ATMPs.

ATMP, Cell & Gene Therapies Series Introduction
June 18, 2021

Meet the Experts! The first episode in the Advanced Therapeutic Medicinal Products or ATMPs series, including Cell & Gene Therapies.

Articles & News

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Articles & News

Valid Insights

Read the latest in industry breakthroughs.

Valid Insights

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.