ICH Q9

Updates to ICH Q9 R1: Quality Risk Management Guidelines
February 23, 2023

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.

Download Transcript

Annex 1

Annex 1: Airflow Visualization Studies
November 30, 2022

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.

ATMP

ATMP/CGT Contamination Control Strategies
November 23, 2022

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
November 16, 2022

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
November 09, 2022

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
November 02, 2022

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
October 26, 2022

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/

Annex 1

The Role of Training in Annex 1 with James Wamsley
October 19, 2022

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
October 12, 2022

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
October 05, 2022

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/