FDA 483 Rehabilitation – A 12 Step Recovery
Key Take Away:
Learn all about FDA 483 observations, warning letters and the basic criteria that the FDA uses to determine its regulatory follow up to your 483 and how to properly layout your 483 rehabilitation plan.
The FDA just inspected your firm and left you a “483,” the dreaded list of the bad things the FDA observed. That’s not a good thing. The FDA 483 observations sets you up for possible administrative action, typically an FDA 483 Warning Letter, or a legal action, such as a seizure of your product. The 483 gives you examples of where you “fell of the wagon.” Your job is to figure out how to get back on the straight and narrow by getting into FDA compliance training.
With the 483 in hand at the close of the inspection, you should start planning your recovery, but where should you start? What happens when the FDA comes back and inspects us again? The 483 gives you a big clue about what the FDA will do during the next inspection. The FDA inspection checklist is a learning tool, albeit one that causes no small degree of corporate pain. The webinar will cover how to interpret a 483 and what you need to do about it to avoid the FDA’s heavy regulatory hammer.
Why Should You Attend:
The FDA 483 gives you a list of what the FDA found to be objectionable. You need to know how to interpret and respond to the 483 on the spot at the end of your inspection. You should proactively plan how you will respond to the investigator and what you will say. Nothing you say or how you behave is “off the record.”
The FDA 483 pulls you out a state of denial. So your next steps in response to the 483 become critical. You are laying out your rehabilitation treatment plan. This means you have a lot of steps to take to correct you defects, such as for quality assurance, corrective and preventive actions, complaint handling, process controls and, where required, reporting to the FDA the bad things associated with the use of your product.
Apart from the FDA, the examples of your problems that appear on your 483, are available to the public. Customers can easily find out that you have problems with the FDA. Your 483 rehabilitation is important to them, but most importantly to you. The FDA will check up on the effectiveness of your regulatory rehabilitation. At a minimum, following some basic steps can bring you back from regulatory disaster.
Areas Covered In This Webinar:
The webinar addresses how the observations are constructed on the 483. In some instances, an observation can mean more than one thing to the FDA. In your rehabilitation plan, how you invest your time and money should get you the biggest bang for your buck. However, reducing your regulatory risk faces financial boundaries.
We will look at some of the basic criteria that the FDA uses to determine its regulatory follow up to your 483 and what factors weigh heavily against you. The factors used by the FDA for evaluating the 483 are the same for each industry sector. Information will be provided so you can step into the FDA’s shoes in that regard.
What you say in your initial response to the 483 tells the FDA what you plan to do to avoid 483 problems in the future. What you do and the timing for implementation is critical. You should know how to steer yourself in the right direction by taking some critical steps to reduce your future risks with the FDA. We will cover what to promise to make and not to make. Your promises give the FDA an indication as to whether “you don’t get it.” Some points will be provided to help you avoid getting jettison into that category.
How to quickly interpret the seriousness of your 483
Deciding on where to spend your resource
Regulatory factors used by the FDA to evaluate your 483
Your promises to correct problems
Laying out your 483 rehabilitation plan
Who Will Benefit:
Regulatory Affairs Managers
Quality Assurance Staff
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. Professional credentials: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.