Everyone breathes a sigh of relief when the FDA investigators depart. But if they left behind a Form 483 pointing out deficiencies and noncompliances, that’s when the work really starts. The FDA allows all establishments receiving a 483 a chance to respond to investigators’ comments and show their commitment to fixing problems and improving operations. The good news is that a well-reasoned response can help a company side step a Warning Letter or worse. The bad news is that the agency gives you only 15 business days to pull it together.
That’s 15 days to:
What happens on Day 16? Nothing … literally. Miss the deadline by just one day and you might as well not have even tried. FDA officials will move ahead with enforcement plans (read “Warning Letter”) without your input. There’s no margin for error.
Is it even possible to do all that – and do it well – in just over two weeks? It is if you have an established, streamlined process and are ready to swing into action as soon as that 483 is placed in your hands.
That’s exactly what Writing a Flawless 483 Response will give you. Based on the popular (literally standing-room-only) workshop presented by John Avellanet, Managing Director and Principal, Cerulean Associates LLC, this 10-minute interactive course will provide you with all the tips, techniques and advice you need to create a quick but critical process for responding to the FDA.
In just 10 minutes, Writing a Flawless 483 Response will teach you all you need to know to respond quickly and effectively to 483s, including
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