Keys to an Effective Technology Transfer as an Element of the Knowledge Management Requirements from ICH Q10 - Webinar By GlobalCompliancePanel

21 March 2013, Fremont, United States

Introduction

The revised Process Validation guideline from 2008 specifically mentions Technology Transfer as a step within Stage 2 - Process Qualification. This requirement demands a concrete policy, agreement between the sender and receiver units, a plan, documentation and conclusions including a signed report that both parties agree that the transfer was conducted and is deemed effective and complete.