FDAnews Announces: No More 483s — QSIT Secrets to Assure Clean Inspections Preconference Workshop for the 12th Annual FDA Inspections Summit, November 1-3, 2017

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Here’s everything devicemakers ever wanted to know about passing FDA device inspections but didn’t know who to ask until now. Find the answers at the No More 483s (12th Annual FDA Inspections Summit) preconference workshop on Nov. 1.


It’s amazing how many devicemakers aren’t QSIT-ready and have the Forms 483 to prove it.

Don’t get tripped up by QSIT. Come to Washington, D.C. Nov. 1 and discover a better way to pass FDA inspections every time.

Devicemakers will learn the hidden secrets to clean inspections by splitting into small groups to flush out specific inspectional problems and discover best-in-class tools and practices that really work.

The instructor is Julie Larsen, Principal/Director, Inspection Readiness Services at BioTeknica. Over the course of four hours of learning-by-doing, she’ll help manufacturers get prepared for their next inspection, showing them:

  • How to use QSIT’s specifics to ensure that internal audits cover and confirm compliance with FDA expectations
  • How to cultivate the art and skill of answering inspectors’ questions promptly and producing documents quickly
  • Best industry tools for internal audits
  • And much more

Attendees will meet companies that used the QSIT in both positive and negative ways.

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

The worst thing manufacturers can do during an inspection is to let it linger. Julie Larsen shows manufacturers how to get the inspector out in a hurry, while never allowing the smile to leave their face.

Conference Details
12th Annual FDA Inspections Summit:
No More 483s: QSIT Secrets to Assure Clean Inspections Preconference Workshop
**Presented by FDAnews**
Nov. 1-3, 2017 – Bethesda, MD

Early Bird Registration (until Sept. 29, 2017):
Complete Summit $1,797
No More 483s Preconference Workshop: $537

Regular Registration (Sept. 30, 2017 on):
Complete Summit $1,997
No More 483s Preconference Workshop: $597

Additional pricing options are available online.

Easy Ways to Register:
Online: http://www.fdanews.com/fdainspectionssummit
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
+1 (703) 538-7665
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