Order today!

Why? Because you’ll save countless post-inspection headaches, up to and including warning letters.

How? With an all-new report from FDAnews that points out what FDA investigators will be looking for ... shows how to spot problems before investigators walk in the door ... and puts post-investigation compliance on a fast track.

Responding to FDA 483s spells out best practices for managing the post-inspection process so you don’t get callbacks from the FDA. Think of it as “483s for Dummies” — a plain-English step-by-step guide that goes beyond boilerplate advice and digs into specifics that help you fashion a top-quality response to your next Form 483.

You’ll discover:

• 483 essentials — the what-works techniques every drug and device manufacturer must know when responding to Form 483s
• Real-world case studies — that show how drug and device manufacturers like you have successfully responded to post-investigation 483 demands
• The FDA’s current focus — what the agency is looking for right now, and which areas are likeliest to lead to warning letters and other post-inspection hassles
• What the FDA won’t tell you — what the Form 483 says and what it actually means — the FDA’s intentions to ensure a satisfactory response from you
• 483s and CAPA — How to structure a convincing CAPA — one that proves to the FDA that your company has adequately addressed 483 observations
• And much more!

The FDA is allowing a mere 15 days post-inspection to respond to Form 483s. If the investigator were to call tomorrow, would you be prepared to meet such a short timetable?

Now — before your next inspection — is the time to ask that question. Now is the moment to order your copy of the latest FDAnews management report.

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Responding to FDA 483s: Strategies for Successfully Obtaining Closeout is available in print and PDF format at the low price of $377. Act now: place your order here. (Add $10 shipping and handling per book for printed books  shipped to the U.S. and Canada, or $35 per book for books shipped elsewhere. Virginia residents, please add 5 percent sales tax.)

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