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Event

FDA 483 Rehabilitation

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.

OverviewThe 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.  Why Should You AttendThe 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.Areas Covered In This WebinarThe 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. Learning ObjectivesHow to quickly interpret the seriousness of your 483Deciding on where to spend your resourceRegulatory factors used by the FDA to evaluate your 483Your promises to correct problemsLaying out your 483 rehabilitation plan Who Will BenefitManufacturersLegal CounselRegulatory Affairs ManagersQuality Assurance StaffOperations DirectorsLevelBeginner

When

29 Mar 2016 @ 01:00 pm

29 Mar 2016 @ 02:00 pm

Duration: 1 hours

Timezone: GMT -5:00


Where

Online Webinar


Language

Englishen


Organised by

AtoZ Compliance (deactivated)

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