Risk Management of Biopharma Operations Over Lifecycle - An ICH Q12 Overview

Join us for a webinar where we’ll delve into the practical application of ICH Q12 principles for biopharma operations. Biotech processes prior to QbD use control strategies that lack understanding of criticality and definition of CPPs or CQAs. Discover how to define these parameters from manufacturing history, and learn how to enhance control strategies through formal risk assessments. Gain insights on aligning with regulatory expectations and optimizing post-approval change management.

In this webinar we’ll explore how to:
• Define CPPs and CQAs from manufacturing history
• Enhance control strategies with risk assessments
• Align with ICH Q12 for regulatory flexibility
• Optimize post-approval change management

Presented by:

José C. Menezes




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