Falls Church, VA (PRWEB)
September 25, 2017
12th Annual FDA Inspections Summit:
Flawless FDA Inspection Handling and Response Preconference Workshop
**Presented by FDAnews**
Nov. 1-3, 2017 – Bethesda, MD
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 …