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Session 5C: Process Validation/Verification - Biologicals
Session Chair(s)
Kowid Ho, PharmD
Pharma Technical Regulatory Policy
F. Hoffmann-La Roche Ltd, Switzerland
Speaker(s)
Integration of Control Strategy, Process Validation and Life Cycle Management for Biologics Process Validation
Ronald Bates
Bristol Myers Squibb, US, United States
Implementation of Evolving Process Validation Principles for Legacy Products
Marco Strohmeier, PharmD
Roche Diagnostics GmbH, Germany
QA Manager
Representative Invited
FDA, United States
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