Writing a Flawless 483 Response: A 10-Minute eLearning Program

$97.00
Training

Product Details

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:

  • Interpret investigators’ observations and “FDA-speak”;
  • Identify and plan corrective actions that will satisfy the agency;
  • Create a draft that makes the most compelling argument for your plans;
  • Develop new SOPs or update old ones, if necessary;
  • Get buy-in from all interested parties in the company;
  • Edit and proofread;
  • Write a summary cover letter; and
  • Deliver the response to the appropriate FDA office.

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.

Featuring video footage from John’s energetic, engaging and entertaining workshop, Writing a Flawless 483 Response is sure to catch and hold your attention, making it easy to retain and apply what you’ve learned.

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

  • How to calculate how many “business days” you have to respond;
  • What FDA investigators really mean when they use standard phrases like “without justification” or “not a statistically sound method”;
  • How to use an Observation Closure Matrix to identify what kind of proof you’ll need to convince the FDA that you’ve resolved problems; and
  • The most important step in the process (hint: don’t just rely on spell check).

Order Your Copy Today!
Product Details
when Price: $97
when Time: 10 minutes

(Add $10 shipping and handling per item shipped to the US or $35 per item shipped elsewhere. VA residents, please add 6 percent sales tax.)

Click here for the eLearning Product Specs.

Who Will Benefit

  • Regulatory affairs/compliance
  • Quality assurance
  • Executive staff
  • Trainers

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