ATMP

ATMP, Cell & Gene Therapies Series Introduction with Jim Vesper

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

ICH Q9

Updates to ICH Q9 R1: Quality Risk Management Guidelines

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.

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Annex 1

Annex 1: Airflow Visualization Studies

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.

Annex 1

The Role of Training in Annex 1 with James Wamsley

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. 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/

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/

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/

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

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/

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/

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.