Martin J. Lipa, PhD

PRST
Executive Director, Knowledge Management
Martin (Marty) Lipa has over 25 years of biopharmaceutical industry experience, including over a decade in Knowledge Management (KM). Marty is currently Senior Research Fellow with the Pharmaceutical Regulatory Science Team (PRST) at TU Dublin and an independent KM consultant. Marty was formerly Executive Director at Merck & Co. where he founded Merck’s KM strategy and delivered significant value enhancing operational efficiency, quality and talent development. Marty is an active member of the global KM community as a regular speaker, author, and volunteer, and has been recognized for his industry contributions through several awards, including by ISPE as the Max Seals Yonker Member of the Year. His prior experience includes various roles in technology, engineering, operations, digital, and validation.

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Integrating Knowledge Management and Quality Risk Management
Features
Integrating Knowledge Management and Quality Risk Management

ISPE held an Expert Xchange on 18 January 2022 entitled “Risk-Based Decision Making: Advancing the Integration of Quality Risk Management (QRM) and Knowledge Management (KM).” The session included presentations and interactive exercises that generated new and useful insights into the current effectiveness of the knowledge that flows into QRM and how a knowledge map can be used to diagnose...

Organization demographics of survey respondents; n = 25, with 20 unique organizations
Online Exclusives
Knowledge Management Implementation: A Survey of the Biopharmaceutical Industry

Knowledge management (KM) has been a recognized discipline for over 20 years in other industries, although within the biopharmaceutical industry, its discussion and formal implementation have been slow to gain momentum. The topic gained regulatory significance in 2008 when the ICH guidance document Pharmaceutical Quality System: Q10 included knowledge management as a key enabler of a...