Flawless FDA Inspection Handling and Response Preconference Workshop for the 12th Annual FDA Inspections Summit, November 1-3, 2017, Bethesda, MD

Inspections Summit 2017

12th Annual FDA Inspections Summit:

Flawless FDA Inspection Handling and Response Preconference Workshop

**Presented by FDAnews**

Nov. 1-3, 2017 – Bethesda, MD

http://www.fdanews.com/fdainspectionssummit

Nine times the FDA inspectors visited. Nine times the drugmaker passed with flying colors. And then, on the tenth inspection it failed.

What went wrong?

Come to Washington, D.C. Nov. 1 and find out.

It’s a repeat of FDAnews’s most popular workshop ever. Discover the hidden secrets to passing FDA drug inspections.

John Avellanet of Cerulean Associates, the industry’s top inspectional readiness expert, is back with a bag full of tips and tricks to ensure drug manufacturers give inspectors what they want every time. Attendees will discover:

  • How to prepare for the inspection
  • How to encourage the investigator to see them in a “state-of-control”
  • And how, if the worst happens, to respond appropriately to a 483 observation.

Over the course of four intense hours of learning-by-doing, Mr. Avellanet will show attendees:

  • Critical inspection preparation techniques that every member of the team should commit to memory (useful for those surprise FDA visits)
  • Hidden tactics investigators use to test drug manufacturers controls. (Never forget: They carry a badge and are taught to probe answers for weakness)
  • Responses to a 483 observation: Inspection responses that cut chances of a warning letter, and getting sign-off from the toughest groups (like legal)
  • And much more

The FDA’s NIPP inspection technique regularly trips up companies with previously clean records. Mr. Avellanet profiles one such company in a case study. The company had years of clean inspections andwas then blindsided by NIPP.

This workshop raises the curtain for the 12th Annual FDA Inspections Summit, Thursday-Friday, Nov. 2-3, 2017. It’s the inspection readiness event of the year for drug and device makers alike.

The worst thing you can do during an inspection is to let it linger. Let John Avellanet show you how to get the inspector out in a hurry.

Conference Details

12th Annual FDA Inspections Summit:

Flawless FDA Inspection Handling and Response Preconference Workshop

**Presented by…

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