CMC Analytical, Comparability and Stability Studies 2014

Key Topics

• Biotechnology Product Specifications; Comparability and Stability Issues
• Biotechnology CMC Regulatory Requirements
• Implementation of Biotechnology Laboratory Tests
• Biotechnology Analytical Methodology
• Discussion of Ongoing Resources for Biotechnology Analytical CMC Issues

Who should Attend

Professionals from Biotechnology, Pharmaceutical, Medical Device and Drug Delivery companies includint:

• Laboratory Supervisors/ Managers
• Stability Directors/ Supervisors/Managers/Analysts/Coordinators
• Quality Control Analytical Chemists
• Project Managers/Coordinators
• Biostatisticians
• Research and Development Chemists
• QA/QC Reviewers
• LIMS Administrators
• Calibration/Metrology Groups
• Validation Scientists
• Manufacturing/Production Managers
• Internal or Independent Auditors