Hosting FDA Regulatory Inspections 2018

Topics

• FDA Inspections: Key factors for a successful FDA inspection
• FDA Inspections: FDA Inspection Program Overview
• FDA Inspections: Information Readiness
• FDA Inspections: Quality System Readiness
• FDA Inspections: Manage Inspection Outcomes
• FDA Inspections: Organization Readiness
• FDA Inspections: Managing Regulatory Risk
• Day 2 Schedule
• FDA Inspections: Medical Device Inspections
• FDA Inspections: Food Facility Inspections
• FDA Inspections: FDA Quality Metrics
• FDA Inspections: 21 CFR 11 Inspections
• FDA Inspections: Writing Effective SOPs
• FDA Inspections: CAPA

Who should Attend

• Nurses
• Physicians
• Operations
• Lab Technicians
• Clinical Data Management