Exploring the Risk-Knowledge Infinity Cycle (RKI Cycle) Across the Product Lifecycle

Complimentary
Learning Level: Intermediate
Time: 1100 - 1200 ET
Session Length: 1 hour

Quality Risk Management (QRM) and Knowledge Management (KM) are positioned as dual enablers to an effective Pharmaceutical Quality System. While there is broad agreement QRM and KM are highly interdependent in principle, there is recognition they are not well integrated in practice, and better integration is an opportunity to better manage risk. A framework, the Risk-Knowledge Infinity Cycle (RKI Cycle), has been proposed to better integrate QRM and KM which can be applied across the entire product lifecycle. Details of the framework are explored as application of the RKI Cycle to the Commercial Manufacturing and Technology Transfer lifecycle phases is illustrated through multiple short case studies, including examples to demonstrate the benefits of effective tacit knowledge transfer. A reimagined PQS foundation is presented, enabled by QRM and KM as intentionally connected and synergistic practices, as a means to improve reduce risk and ultimately benefit patients.

Learning Objectives

  1. Understand the relationship of QRM and KM
  2. Understanding of the Risk-Knowledge Infinity Cycle (RKI Cycle)
  3. Review of the Risk Knowledge Infinity Cycle (RKI Cycle) in the Context of Technology Transfer
  4. Review of Case studies to understand the RKI cycle

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Speakers

Alice Redmond, PhD
Chief Strategy Officer
CAI
Marty Lipa
Executive Director- Knowledge Management
MERCK
Kevin O'Donnell, PhD
Market Compliance Mgr & Sr Inspector
Health Products Regulatory Authority (HPRA)
Valerie Mulholland
Snr Consultant
GMP Services Ltd

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