Process Validation for Biotechnological Products MasterClass - US edition

The Process Validation for Biotechnological Products MasterClass - US edition covers key methodologies in process validation for biotechnological products, focusing on control strategies, qualification processes, and regulatory compliance.

Key Topics

• Control strategy development
• Process performance qualification and stability studies
• Clearance of impurities and worst-case studies
• Determining the number of process performance qualification (PPQ) runs
• Continued process verification purpose and design
• Qualification of cell banks
• Establishing critical quality attributes (CQAs), critical material attributes (CMAs), and critical process parameters (CPPs)

Who should Attend

• Quality control professionals
• Process validation specialists
• Regulatory affairs professionals
• Bioprocess engineers
• Pharmaceutical industry professionals
• Manufacturing and production managers
• Scientists in biotechnology and biopharmaceuticals