FDAnews Announces: Save the Date for 11th Annual FDA Inspections Summit, November 2-4, 2016

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Over the past 10 years thousands of industry professionals have attended the FDA Inspections Summit and benefited from the unmatched presentations and panel discussions led by FDA officials and industry experts. The 2016 FDA Inspections Summit will take place from November 2nd to November 4th in Bethesda, MD.

11th Annual FDA Inspections Summit:
**Presented by FDAnews**
Nov. 2-4, 2016 – Bethesda, MD

FDAnews is in the process of creating a groundbreaking three-day agenda that will provide attendees with a deep dive into all the key issues confronting quality assurance professionals, with actionable information and insights that can be taken back and apply immediately.

The following speakers have been invited to speak at this year’s Summit:

From the FDA:

  •     CAPT Cynthia Harris, Bioresearch Monitoring Specialist, ORA, FDA, Baltimore District Office
  •     Karthik Iyer, Acting Branch Chief, Quality Intelligence Branch, OC, OPQ, CDER, FDA
  •     Lori Lawless, SCSO, Medical Device Specialist, ORA, FDA, Baltimore District
  •     Mary Anne Malarkey, Director, Office of Compliance and Biologics Quality, CBER, FDA
  •     Marc Neubauer, CSO, Medical Device Specialist, ORA, FDA, Baltimore District
  •     Robin Newman, Director, Office of Compliance, CDRH, FDA
  •     Phil Pontikos, CSO, National Device Expert, OMPTO, ORA, FDA, Columbus, OH
  •     Douglas Stearns, Director, Office of Enforcement and Import Operations, ORA, FDA
  •     Dr. Lawrence Yu, Deputy Director, Office Product Quality, CDER, FDA

Industry Experts:

  •     John Avellanet, Managing Director and Principal, Cerulean Associates LLC
  •     David Chesney, Vice President, Strategic Compliance Services, PAREXEL Consulting
  •     John C. (Jack) Garvey, Principal, CEO, Compliance Architects LLC
  •     Julie Larsen, Senior Partner, Director Inspection Readiness Services, BioTeknica
  •     Elaine Messa, President, NSF Health Sciences, Medical Device Consulting; former director of the Los Angeles District, FDA
  •     Steve Niedelman, Lead Quality Systems and Compliance Consultant, King and Spalding, former FDA Deputy Associate Commissioner for Regulatory Operations
  •     Dan O’Leary, President, Ombu Enterprises
  •     Vicky Stoakes, President, IntegRx, Inc.; former FDA Chemist, ACNA and Investigator, Atlanta District Office Drug Cadre

Please check the Inspections Summit website and sign up to receive updates and the complete agenda as soon as it is available.

Register today and take advantage of “early bird” pricing. Simply use promo code INSP16 when registering to take advantage of an extra 20% off.

Conference Details:
11th Annual FDA Inspections Summit:
**Presented by FDAnews**
Nov. 2-4, 2016 – Bethesda, MD

Early Bird Registration (until Sept. 30, 2016): Complete Summit $1,797
Regular Registration (Sept. 30, 2016 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.

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Michelle Butler
+1 (703) 538-7665
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