FDA`s Risk Evaluation and Mitigation Strategy (REMS 2019)

Topics

• Shared Systems REMS
• Overview of REMS Elements
• Best Practices to Address Inspection Findings
• The REMS Inspection Process
• Preparing for REMS Inspections
• REMS Specific Issues

Who should Attend

• Engineering Departments
• Quality Assurance Departments
• Validation Departments
• Operations Departments
• Quality Engineers