FDA Warning Letter Close-Out Program 2014

Key Topics

• FDA Enforcement and Compliance Manuals
• Applicable Laws and Regulations
• Hosting an FDA Inspection
• FDA Inspection Guides
• FDA Forms 482 and 483
• Factors/Matters Leading to Warning Letters
• The Common Deficiencies during FDA Inspections for Firms (Food, Devices, and Pharmaceuticals)
• Establishment Inspection Reports (EIRs)
• What to Discuss During Close Out Meeting at the End of an Inspection
• How to Communicate Before, During and After FDA Inspection: Dos and Don’ts
• Dealing with Warning Letters
• Responding to 483s, if issued
• FDA’s Warning Letter "Close-Out" Program
• Consequences of Inadequate Corrections and Repetitive Violations
• When FDA Issues a Close-Out Letter
• Warning Letter Close-Out Timelines based on 32 Cases
• Good Practices
• When FDA Doesn’t Issue a Close-Out Letter

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