Topics
- Feasibility and timeline
- Regulatory background
- Storage of cell banks to certify stability
- Preparation of cell banks to ensure consistency
- Appropriate documentation plans for protocols and certificate of analysis
- Risk-based characterization strategy
Who should Attend
Personnell from biotech and pharmaceutical companies, including Pharmacokinetic/Pharmacodynamic analysts, Bioassay specialists, QA/QC, Neutralization biologists, Regulatory personnel, Project Managers and Consultants.
