FDA Inspection: Preparation and Management 2014

Key Topics

• FDA Manuals
• Applicable Laws and Regulations
• Hosting an FDA Inspection
• Inspection Guides
• Inspection Types and Categories
• Field Management Directives
• FDA Forms 482 and 483
• Inspection Classification
• What/How to Prepare for and Manage an FDA Inspection
• Establishment Inspection Reports (EIRs)
• Inspection Preparation Procedures
• How to Communicate Before, During and After inspection: Dos and Don’ts
• Responding to 483s, If Issued
• Close Out Meeting
• Employee Training
• How to Communicate with Emotional Intelligence
• Conclusion
• Actual Case Studies

Who should Attend

• VPs
• CEOs
• Attorneys
• Compliance Officers
• Clinical Affairs
• Regulatory Affairs
• R&D
• Quality Assurance
• Contractors/Subcontractors
• Consultants
• Anyone Interested in the FDA inspection Process