Managing an FDA Inspection 2017

Topics

• Inspection preparedness strategy and planning
• FDA Inspection basics
• SME (Subject Matter Expert)training
• Key roles during an inspection
• How to manage an inspection
• Checklists for preparing
• How to respond to inspection observations
• Common mistakes to avoid

Who should Attend

Attendees with responsibilities in:

• Compliance Specialists
• Quality Engineers
• Quality Managers
• Compliance Managers
• Business Leaders wishing to present a professional and compliant organization
• Consultants and Contractors
• Anyone involved with an FDA or NB inspection
• Cross-functional leaders wanting to make sure their organizations are well prepared