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FDAnews Announces: 9th Annual FDA Inspections Summit, Oct. 22-24, 2014, Bethesda, MD
Date:8/25/2014

ty 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: Newe
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