Implementation of QbD: An FDA Perspective ( WEBIMPQBD )
Description:
This presentation provides a background of current FDA and ICH initiatives and guidance for product quality. It presents activities and experience in the Office of New Drug Quality Assessment (ONDQA) to support Quality by Design (QbD) approaches. Finally, considerations for QbD submissions are provided.
Objectives:
At the conclusion of this session, participants will be able to:
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