Managing Your FDA Inspection: Before, During and After

FDA inspects many different kinds of firms. If the FDA regulates your product, they can show up at your lobby and say, “I am here to conduct an inspection.” What do you do? What have you done to prepare for an inspection? How do you deal with the investigator, including their personality? The scary part is having to explain the error of your ways to the FDA and above all, managing an administrative action, e.g., Warning Letter or Import Alert, or a legal action, e.g., civil money penalties, seizure, injunction or prosecution. This course will help you need to know and what you should do to survive an FDA inspection with the least possible pain.

• FDA legal authority to inspect
  • Over products
  • Over firm’s
    • Scientific/clinical studies
    • Premarket requirements
    • Postmarket requirements
• FDA’s annual inspection work plan
• Inspection Procedures
  • FDA inspection Manuals
  • FDA Training
  • Documenting violations
  • Refusals
  • Human factors

When you interact with the FDA, you need to look at yourself through FDA’s eyes. You can understand the purpose of an inspection, what the investigator will do and what it means for you. Once you learn how to read the signals you are better equipped to mitigate regulatory damage and, best of all, take the drama and mystique out of an inspection. The information in the course gives you rational and comprehensive approach so you do not feel like a deer staring at the headlights. If you know what the investigator is doing and you understand your job, your receptionist will not need a panic button.

• Regulatory Affairs Directors
• Quality Assurance Managers
• Quality Control Managers
• Manufacturing Directors and Managers
• Product Risk Managers
• Venture Capitalists

Note: Use coupon code REFERRAL10 and get 10% off on registration.