Preparing for FDA BIMO Inspection and Management 2014

Topics

• Definitions
• Statutes and Regulations
• Regulatory Requirements for Compliance
• FDA Manuals
• Inspection Types and Categories
• FDA BIMO Inspection: Scope and Depth
• Inspection Process
• Inspection Classification
• How to Answer Questions
• Hosting an FDA Inspection
• Dos and Don`ts Before, During and After FDA Inspection
• FDA Forms 482 and 483
• Misconception and Frequent Mistakes
• Responding to 483: Best Practices
• Improving Awareness
• Enforcement Cases
• Good Business and Employment Practices
• Exercising Sound Judgment
• Practical, Actionable and Sustainable Recommendations: Best Practices
• Transparency, Accountability and Integrity

Who should Attend

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