Falls Church, VA (PRWEB)
September 21, 2017
12th Annual FDA Inspections Summit:
**Presented by FDAnews**
Nov. 1-3, 2017 – Bethesda, MD
Early bird pricing for the 12th Annual FDA Inspections Summit ends on Friday, Sept. 29.
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. Here’s where attendees:
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.
Drug and device separate 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.
Early bird pricing ends on Friday, Sept. 29.
FDA Speakers Include:
Ellen Morrison, Associate Commissioner, OMPTO, ORA, FDA
Dara Corrigan, J.D., Associate Commissioner, Office of Global Regulatory Operations and Policy, OC, FDA
Carol Bennett, JD, Deputy Director, Office of Regulatory Policy, CDER, FDA (Invited)
Robin Newman, Director, Office of Compliance, CDRH, FDA…