Introduction
This book has three parts. Part I establishes the framework for what follows. It considers how a systematic approach to problem solving can lead to continuous improvement of program and process in the life sciences industry. Program improvement carries its own consequences. Controlled change, a crucial aspect of program improvement in regulated industry, results in the revision of controlled documents - standard operating procedures (SOPs). These revisions in turn require training of all employees impacted by the change.
Part II provides an overview of the development of several kinds of GXP training modules. Part III addresses the implementation, assessment, record-keeping, and evaluation of those training modules.
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