Topics
- Laws and Regulations in the U.S
- Introduction to U.S. Drug Regulation
- Violations and Responses
- The U.S. Drug GMP
- An Overview of ICH Q8, Q9, and Q10
- Filings and Submissions - DMF and Clinical Trials
- Biosimilars in the U.S., An Overview
- Risk Analysis and Corrective and Preventive Actions (CAPA)
- Process Validation
Who should Attend
Vice Presidents of Technical Departments, Presidents, Directors, Managers, Quality, Regulatory Associates and Analysts, Research, Regulatory and Development Group Heads.
