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In this week's edition of Risk Revolution, Stacey is joined by Nuala Calnan and Marty Lipa to discuss the Risk Knowledge Infinity Cycle. Stacey, Nuala, and Marty also chat about the ways Risk Management and Knowledge Management work together to provide a more effective Quality Management System and the two enablers to building an effective Quality Management System, QRM and KM, which really have been kept separate in the industry but should be working together.
Risk Revolution, a monthly series of the Voices in Validation, brought to you by the IVT Network. This series aims to advance the maturity of risk management practices within the industry, addressing topics that challenge quality professionals to seek opportunities to improve and advance how they perceive and manage risk.
Resources from this episode:
ISPE’s KM Good Practice Guide
T.U. Dublin’s : A Survey Report on the Current State of QRM and KM Integration
Knowledge As The Currency Of Managing Risk: A Novel Framework To Unite Quality Risk Management And Knowledge Managemen
Managing Knowledge and Risk – A Literature Review on the Interdependency of QRM and KM as ICH Q10 Enablers
Effective Knowledge Transfer During Biopharmaceutical Technology Transfer
Turning Knowledge Into an Asset in Pharmaceuticals – PODCAST
About Our Guest:
Marty Lipa
Marty Lipa, is the Executive Director - Knowledge Management at Merck. Marty has over 27 years in the biopharmaceutical industry and has led the KM Center of Excellence for Merck manufacturing for the last 11 years. Marty has recently completed the requirements for his Ph.D. at TU Dublin with an emphasis KM and its connection to QRM.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. |