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.
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
