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ISPE GPG: Knowledge Management (Download) - USD
ISPE GPG: Knowledge Management (Download) - USD
Good Practice Guide: Knowledge Management in Pharmaceutical Industry
Discounted member price: 295.00
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ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Embracing these objectives can be best achieved using the dual enablers, Knowledge Management (KM) and Quality Risk Management (QRM). The first reference to KM in the field of pharmaceutical quality was in ICH Q8 in 2005 as a tool used with QRM for a more systematic Quality by Design (QbD) approach to development throughout the product lifecycle. Three years later, ICH Q10 identified KM and QRM as the enablers of an effective Pharmaceutical Quality System (PQS). Since then, the pharmaceutical industry has made significant progress in adopting QRM into systems and processes. However, the industry has been slow in implementing KM, thus missing the quality, operational, and employee engagement advantages KM practices have to offer. The ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry discusses how KM can enable a more effective PQS. The first such guidance in the pharmaceutical industry, the Guide promotes uniting KM with QRM to enable better risk-based decisions, and shows how KM can enhance nearly every element of the PQS across the product lifecycle.

Member Price: $ 295.00 / € 268.00
Non Member Price: $ 595.00 / € 541.00

ISBN: 978-1-946964-42-7
Author: ISPE
Publisher: ISPE
Format: Download
Pages: 160
Publishing Date: 05/21