The inaugural 2019 PDA Quality Week, Dec. 9-13 at the Capital Hilton in Washington, DC, presents not only one conference, but two conferences and a workshop.
The Week concludes Dec. 12-13 with the second Conference, Optimizing Quality Risk Management, which will highlight the challenges and opportunities an organization faces when designing and implementing a holistic QRM program.
Topics such as “Harnessing the Power of Quality Risk Management” will be addressed through a discussion with industry leaders and regulators on the importance of QRM and how an effective program can provide organizations with a way to understand and mitigate risks to patients. Real-life practical examples of how industry is applying QRM will be shared.
The topic of “Quality Risk Management as a Strategic Driver in the Organization” addresses designing and implementing a holistic QRM program and the challenges around it. Discussion will focus on how QRM is less of a toolset and more of a strategic capability.
In this session, attendees will engage with a panel of experts and hear directly from industry leaders on their companies’ QRM programs and underlying strategies. The interactive panel discussion will cover many aspects and challenges to developing, maintaining, and sponsoring QRM programs and capabilities.
"Deploying QRM” is another topic of this important second Conference of the Week. ICH Q9 and ICH Q10, Pharmaceutical Quality System, both reference where quality risk management principles should be applied in the Quality Management System. However, there is very little instruction and “how to” guidance in either of these documents, with respect to building processes for implementing the suggested approaches. Attendees will have the opportunity to discuss examples of QRM integration into the quality systems.
This Conference will conclude with a QRM compliance update in which leading regulators will provide their perspectives on the use of QRM and practical aspects of QRM.