PDA Letter Article

Supporting the Quality Risk Management Framework

by Denyse Baker, AstraZeneca, and Steven Mendivil, Quality Beyond Compliance

Quality Metrics

Active Learning, Key Opinion Leaders Highlight PDA Quality Week

Are you looking to learn the latest in quality risk management (QRM)?Do you want to know more about the role of quality culture in applying QRM?

The 2019 PDA Quality Week will consist of three meetings that build on each other so that participants bring home a range of QRM knowledge. The first conference, Risk Management in the Regulatory Landscape, will provide a foundation on the role of quality culture in supporting QRM. This conference will be followed by the one-day workshop, Building a Foundation and Culture for Quality Risk Management Integration. The final two-day conference, Optimizing Quality Risk Management, will focus on implementing QRM programs within a quality management system.

In addition to U.S. FDA CDER Director Janet Woodcock, who will kick off Quality Week, the program planning committee has invited a representative from the FDA’s Office of Pharmaceutical Quality (OPQ) for updates on CDER’s quality metrics program, the Inspectional Risk Program and how FDA uses QRM principles to prioritize patient safety. This will be an opportunity to hear about any outcomes from the two quality metrics feedback programs announced a year ago and what FDA has learned from them.

The second day of Quality Week will prioritize ICH Q9: Quality Risk Management, the foundation of the QRM systems used today. Greg Claycamp (formerly of FDA) and Stephan Roenninger (Amgen) have been invited to speak on the ten-year impact of ICH Q9 and discuss any plans to update it. Both were on the original ICH Q9 Expert Working Group and are knowledgeable about the latest plans for this important ICH guideline.

You will also have an opportunity to hear from key industry leaders on QRM. Guy Villax, CEO, Hovione, has been invited to kick off Wednesday’s workshop with a talk on how to integrate QRM into assessing the broader risks a company faces.

Make your plans now to join us for an exciting week of learning and networking.

Learn more about the inaugural 2019 PDA Quality Week!