A-Cell: Generation of QTPP, Risk Assessment and Critical Quality Attribute Identification

  Рет қаралды 2,830

Alliance for Regenerative Medicine

Alliance for Regenerative Medicine

Жыл бұрын

This webinar will cover the elements of Quality by Design for cell-based therapies, including the QTPP as a product development and life cycle management tool, and risk assessment approaches to identify product CQAs and critical process parameters (CPPs). The speaker will then explain how developing a good understanding of the inter-relationships between CPPs, CQAs and clinical outcomes is fundamental to the implementation of an effective control strategy, leading to greater assurance of product quality.
Speaker:
Pinar Cicalese, Ph.D., Director CMC Commercial Strategy, Immatics

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