The articulation of an integrated control strategy in a QbD framework is a targeted outcome of product and process development.  To fully enable quality system integration, product and process knowledge needs to be effectively communicated and transferred to different stakeholders both internally and externally (e.g. commercial manufacturing, and regulatory authorities).  This presentation will highlight examples demonstrating how the translation of the different elements of the control strategy from the knowledge generators to the knowledge users, with the appropriate context, supports the product lifecycle.  Specifically, the case study will follow the development of a control strategy for a CQA from development, through PPQ and filing, to control in the manufacturing plant including post-approval changes.   Opportunities for improved knowledge flow will be discussed.<br/>

Practical considerations of knowledge management as an enabler of quality throughout the product lifecycle

253rd National Meeting (2017)

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