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.
Learning Objectives:
- 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
- Recall procedures (What FDA expects from you.)
- FDA Field Office Management
- FDA Center(s) Management
- The firm’s job
- Inspectional observations (Form FDA-483)
- Responding to a 483
- Responding to a Warning Letter
- FDA enforcement actions
- Follow up inspections
- Foreign Inspections
Who will Benefit:
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
Topic Background:
FDA inspections can have a big impact on a firm’s budget, public image, customers, employees and stockholders. No one wants the bad news that the FDA investigator puts on a written list of observations, aka the “483.” Your 483 is like a report card that your teacher shows to everyone else in the class. What an investigator finds pulls together many different legal, administrative and technical factors that end up showing you and the public where you stand with the FDA. Inspections cover a wide range of products and an equally broad range of establishments, so preparing for and understanding an inspection takes work that is specific to your firm.
FDA inspections are assigned for many different reasons. Safety (risk to health) plays a major role in how FDA selects firms for inspections. Firms can estimate their likely risk status in terms of FDA’s regulatory interest. Once a firm is selected for inspection, how the inspection is conducted becomes a make-or-break situation. Inspections are designed to find problems. They are inherently uncomfortable for the people who host the investigator during the inspection. Predicting what an investigator will do during an inspection becomes helpful in how you manage a difficult situation to avoid a potentially disastrous and costly result.
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