[
Webinar
|
July 28, 2022
]

Accelerating QbD: Perspectives on Product Risk Assessments for Advanced Biologics

Perspectives on Product Risk Assessments for Advanced Biologics

A 60-minute cross-industry panel of experts will share their perspectives on conducting product risk assessments for biologics under a holistic, Quality-by-Design (QbD) framework.

Drug sponsors, practitioners, regulatory professionals, pharmaceutical executives, academics, and other interested parties will gain an understanding of how to apply these principles as described in the ICH guidelines. The discussion will be based on real-world experiences and best practices that produce more complete and comprehensive submissions

Speakers
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 I
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 I
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Tech Transfer
[
Senior Director Technical Operations and Head of Biologics Development
]

Praveen Prasanna

[
Principal Engineer
]

Mark Mitchell

Mark Mitchell is a Principal Engineer at Pharmatech Associates, where he advises life science manufacturers on process validation and control strategy. He is the author of the three-part BioPharm International series Determining Criticality: Process Parameters and Quality Attributes, which sets out a practical roadmap for applying scientific knowledge, risk analysis, experimental data, and process monitoring across the stages of the process validation lifecycle, and introduces the concept of a continuum of criticality.

[
Head of Quality
]

Rebecca Waterbury

[
Director of Product and Process Development
]

Barrett Fallentine