Annex 1

Annex 1: What’s Been Happening?

In this podcast, Jim Vesper speaks with four ValSource Consultants who have been presenting at or attending Annex 1 workshops across the U.S., Europe and Asia. Tune in for insights from industry experts Amanda McFarland, Fred Ayers, Kim Sobien and James Wamsley.

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. Learn about how ValSource can support your Annex 1 planning: https://valsource.com/annex1-gap-analysis/

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. Learn about how ValSource can support your Annex 1 planning: https://valsource.com/annex1-gap-analysis/

ATMP

ATMPs: Regulations & 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. Learn about how ValSource can support your Annex 1 planning: https://valsource.com/annex1-gap-analysis/

ATMP

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. Learn about how ValSource can support your Annex 1 planning: https://valsource.com/annex1-gap-analysis/

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/