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FDAnews Announces: 9th Annual FDA Inspections Summit, Oct. 22-24, 2014, Bethesda, MD

FALLS CHURCH, Va., Aug. 25, 2014 /PRNewswire-iReach/ --

9th Annual FDA Inspections Summit
**Presented by FDAnews**
Oct. 22-24, 2014 – Bethesda, MD

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What's the state of FDA's Quality Metrics Initiative? When will drug and devicemakers have to start collecting data? What will they have to track?

And where does the agency stand on the reorganization of its inspectional operations? What will that mean to the industry?

Get those questions answered and many more, at the 9th Annual FDA Inspection Summit, sponsored by FDAnews.

With twin tracks for drug/biologics and device manufacturers, attendees will discover sessions and panels for every FDA-regulated company.

  • For drug and biologics makers, there's a standout panel on the 10 best, and 10 worst things to do during a drug or biologics inspection.
  • Devicemakers will hear FDA investigator Lori Lawless spell out the intricacies of QSIT, with emphasis on making sure the seven subsystems are in compliance and properly linked.
  • And all attendees will be on the edge of their seats as experts from within and outside the agency pass along proven secrets to FDA success.

The people attendees want to see are right there in the room, rubbing elbows. Multiple FDAers have been invited including:

  • Kimberly Trautman, Associate Director, International Affairs, Medical Device International Quality Systems Expert, Office of the Center Director, CDRH
  • Dr. Neil Stiber, Operations Research Analyst, Office of Strategic Programs, CDER, FDA
  • Kirk Sooter, District Director, Philadelphia District Office, ORA, FDA
  • Lori Lawless, SCSO, Medical Device Specialist, ORA, Baltimore District
  • Marc Neubauer, CSO, Medical Device Specialist, ORA, FDA, Baltimore District
  • Capt. Cynthia Harris, SRO, Medical Device/Bioresearch Monitor, ORA, FDA, Baltimore District

Plus many former FDA insiders have been invited among the private-sector panelists:

  • Former Los Angeles District Director Elaine Messa, head of the Medical Device Practice at Becker & Associates Consulting
  • Former FDA investigator Vicky Stoakes, now President, IntegRx
  • Former FDA Deputy Associate Commissioner for Regulatory Operations, Steve Niedelman, now Lead Quality Systems and Compliance Consultant, King and Spalding

These are just a few of the many speakers at this year's Inspection Summit. 

Over two days, attendees will discover solutions to the sort of problems that keep them up at night:

  • Latest on the FDA's Quality Metrics Initiative
  • A day in the life of an FDA field investigator: Current and former investigators explain what they look for, and why and what's on the horizon
  • CBER inspectional findings: A review of recent Warning Letters
  • Update: The International Medical Device Regulators Forum's single-audit program
  • Curbing 483s: Newest and most successful "learning" methods
  • And much more

Conference Details:
9th Annual FDA Inspections Summit
**Presented by FDAnews**
Oct. 22-24, 2014 – Bethesda, MD

Early Bird Registration (until Sept. 19, 2014): Complete Summit $1,797
Regular Registration (Sept. 20, 2014 on): Complete Summit $1,997
Additional pricing options are available online.

Easy Ways to Register:
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.

Media Contact: Michelle Butler, FDAnews, 703-538-7665,

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