The FDA expects organizations to have full visibility and control over their processes

A free white paper by Dassault Systèmes BIOVIA

Expectations include: • Understanding products and processes in order to implement Quality by Design (QbD) into product development • Delivery of quality metrics for risk-based inspection schedules as proposed by a new quality metrics program • Shared responsibility for products manufactured by their Contract Manufacturing Organizations (CMOs) • Drive improvements in manufacturing technology, product quality and safety - reducing recalls and mitigating drug shortages

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