The words “FDA inspection” can strike fear into the hearts of even the most stalwart medical device manufacturers, but with proper preparation and training, you won’t have to sweat the details when the FDA inspectors show up at your facility. Instead, you’ll be prepared and confident in your ability to provide the right documentation.
Although it might seem like all the fun occurs in the front room, the effectiveness of the back room management is the real deciding factor in most successful inspections. In fact, the back room is often called the “war room” because FDA audit battles can be won and lost there. It’s safe to say that a well-prepared, well-organized back room is the most crucial element of FDA inspection management, enabling you to react quickly and appropriately to virtually any FDA inspector request and predicting where the inspector will go next. Just as important, the back room gives you the opportunity to assess, review, and approve any and all documentation being delivered to the front room before it's given to the inspectors, ensuring fewer surprises and awkward delays or explanations.
The back room and the front room must work hand in hand to ensure all inspectors' requests are understood. The scribes and the front room lead must communicate well and the back room must be able to translate those requests into specific answers. Not too much information, not too little, just enough to satisfy the request.
Here are five tips for setting up and managing a proper FDA audit back room:
1. Effective leadership
Assign a back room leader who works well under pressure and can manage the subject matter experts (SMEs). The leader must be like an orchestra conductor, making sure everyone is prepared and comes and goes into the front room at exactly the right time.
2. Delegation
No one person can do it all. The leader must quickly identify potential needs that can come up during an inspection and make sure the people are available to address them. This might include not only SMEs but also IT personnel for printers, copiers, and archived files.
3. Proper provisioning
Start with a support team that can accommodate the majority of inspector requests, including having documentation ready for higher risk and more current products. This is particularly important if you know weaknesses exist that may require further explanation. Have the right equipment available for them to work with, such as computers and Internet access, to help gather and disseminate information internally and to the FDA inspectors.
4. Effective communications
The back room leader needs to be kept current with everything that’s going on in the investigation rooms through face-to-face interaction or text/chat capabilities so he or she can properly coordinate and provide timely responses to requests.
5. Standard operating procedure
Develop and distribute an SOP guide to all employees — an FDA inspection will go much smoother if everyone in the front and back rooms understands their responsibilities prior to and during an FDA inspection. Assign various roles to the appropriate personnel and make sure they have back-ups (see tip #3).
If you implement these five back room management tips, you’ll be on track in your preparation for an FDA audit. If you have questions or would be more confident with professional assistance, visit our website or call us at 508-231-8842.