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FDAnews Announces: 12th Annual FDA Inspections Summit, November 1-3, 2017, Bethesda, MD
Date:8/28/2017

12th Annual FDA Inspections Summit:
**Presented by FDAnews**
Nov. 1-3, 2017 – Bethesda, MD
http://www.fdanews.com/fdainspectionssummit

The FDA has a new Commissioner, Scott Gottlieb, and everyone in the drug and medical device industry has heard all the talk about fewer regulations and efforts by the agency to use more “carrot” and less “stick.” The approach typically changes whenever a new administration, and new Commissioner, take the reins.

But the FDA always does inspections, and is forever looking for a way to do them differently and better.

Manufacturers can’t afford to be caught off guard. Warning letters, 483 citations, and reputation hits can cost manufacturers time, energy and money.

Come to Washington, DC, Nov. 1-3, for the 12th Annual FDA Inspections Summit, the must-attend conference of the regulatory year from FDAnews.

Meet the FDAers whose actions spell fortune, or failure, lawyers and consultants who fight for manufacturers, industry hot-shots who’ve sussed out how to navigate a hyper-regulated milieu and still prosper.

Discover how the reorganization of the ORA affects specific products, the metrics revolution that is pointing quality regulation in a new direction, the new rules affecting postmarket adverse event reporting and cGMP, how to deal with difficult inspections and more.

Ask the inspectors anything and hear them talk candidly about what will change the next time they visit.

There are separate drug and device tracks. There’ll be panels galore aimed specifically at the particular issues that affect drug and device makers.

Pre-Conference Drug and Device Workshops are filled with tips and tricks to help manufacturers sail through their next inspection.

FDA Speakers Include:
Ellen Morrison, Associate Commissioner, OMPTO, ORA, FDA
Carol Bennett, JD, Deputy Director, Office of Regulatory Policy, CDER, FDA (Invited)
Dara Corrigan, J.D., Associate Commissioner, Office of Global Regulatory Operations and Policy, OC, FDA (Invited)
Robin Newman, Director, Office of Compliance, CDRH, FDA (Invited)
Douglas Stearns, Director, Office of Enforcement and Import Operations, ORA (Invited)

Who Will Benefit:

  • Drugmakers
  • Devicemakers
  • Biologics firms
  • Diagnostics firms
  • Executive suite
  • Manufacturing/GMP
  • QA/QC
  • Regulatory affairs
  • Strategic planners
  • Legal counsel
  • Consultants

Conference Details
12th Annual FDA Inspections Summit:
**Presented by FDAnews**
Nov. 1-3, 2017 – Bethesda, MD
http://www.fdanews.com/fdainspectionssummit

Tuition:
Early Bird Registration (until Sept. 29, 2017): Complete Summit $1,797
Regular Registration (Sept. 30, 2017 on): Complete Summit $1,997
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.

Read the full story at http://www.prweb.com/releases/FDAnews/fdainspectionssummit/prweb14629541.htm.


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