PDA Letter Article

Incorporating QRM into Cell and Gene Therapy Processes

by Lori Richter, ValSource, and Ghada Haddad, Merck


The principles of quality risk management (QRM) are certainly not new with ICH Q9: Quality Risk Management and ISO 14971 Medical Devices—Application of Risk Management to Medical Devices being present in the industry for quite some time now. But do these concepts pose unique challenges for implementing QRM within the cell and gene therapy space?

Cell and gene therapy processes can differ from traditional manufacturing. This may result in a variety of challenges when integrating QRM methodologies into decision-making. Current manufacturing technologies require human interventions which inherently introduce risk.

These issues and more will be discussed at the inaugural 2019 PDA Quality Week. The theme of this conference series is “Mastering Risk Management for Organizational Success,” and the series will focus on various aspects related to QRM.

The first meeting for the week is titled Risk Management in the Regulatory Landscape and is scheduled for Dec. 9–10. This phase will provide participants with background on QRM. The second phase of this conference week is a workshop scheduled for Dec. 11, Building a Foundation and Culture for Quality Risk Management Integration. This workshop will focus on the basic foundational elements needed to incorporate risk management thinking into the company culture throughout the organization. The final phase of this conference series is Optimizing Quality Risk Management and it will give attendees the necessary tools and concepts to help them implement and sustain a successful QRM program. During this session Monica Hueg, Managing Consultant, NNE Denmark, and Tais Conti, Quality and Compliance Department Manager, Bristol-Myers Squibb Company, have been invited to speak on the topic of executing QRM in advanced cell and gene therapy biologics.

Join us for an opportunity to get into some in-depth and insightful conversations regarding QRM in the biopharmaceutical industry!

Learn more about the 2019 PDA Quality Week.