Expert Xchange: Risk Based Decision Making: Advancing the Integration of QRM & KM

Learning Level: Intermediate
Session Length: 3 hours

In this highly interactive session, attendees will have the opportunity to explore how the thoughtful integration of Quality Risk Management (QRM) and Knowledge Management (KM) can lead to more informed decision making across the Pharmaceutical Quality System (PQS) during technology transfer and commercial manufacturing. The discussion will be led by regulatory science researchers from TU Dublin and industry experts.

A novel framework to intentionally unite QRM and KM, the Risk-Knowledge Infinity Cycle (RKI Cycle), was first introduced in May 2021 through the ISPE Good Practice Guide on Knowledge Management in the Pharmaceutical Industry and an ISPE Webinar, Exploring the RKI Cycle Across the Product Lifecycle. The RKI Cycle will be presented in brief to orient the attendees, followed by a presentation on risk-based decision making. These presentations will be followed by breakout sessions to engage with the experts and fellow participants on how they view the potential opportunity and impact of the RKI Cycle, as well as potential implementation challenges.

First-hand Strategic Insights & Actionable Takeaways 

1. An introduction to the Risk-Knowledge Infinity Cycle (RKI Cycle) as a framework to unite QRM and KM
2. An introduction to risk-based decision making (i.e., decisions based on science and evidence), and how the RKI Cycle can further enable risk-based decision making
3. Preliminary considerations & opportunities for where the RKI Cycle may be deployed to drive more informed decisions for technology transfer and commercial manufacturing
4. Download Knowledge Map Template
5. Attendee Survey

Download Presentations

ISPE Expert Xchange Session Speakers

Marty Lipa

Executive Director- Knowledge Management

MERCK

Anne Greene, PhD

Professor

TU Dublin

Valerie Mulholland

Snr Consultant

GMP Services Ltd