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.