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Lori's general medical device FDA inspectional and GAP analysis work experience includes the firm types as follows:

  • Foreign and Domestic/Routine and Directed Inspections
  • Pre-market and Post-market/PMA and 510(k)
  • Class I, Class II, and Class III
  • High Risk/Life Sustaining Medical Devices
  • Contract gamma, electron beam, and ethylene oxide sterilization facilities

In this role, she inspected domestic and international medical device companies to compliance with FDA's regulation for medical devices (21 CFR 820).

Lori has provided training during the FDA National Basic Medical Device School which trains FDA Medical Device Investigators and to numerous industry groups on various medical device topics including:

  • 21 CFR 820
  • QSIT (Quality System Inspectional Technique)
  • CAPA (Corrective and Preventive Action)
  • Internal Auditing
  • Statistical techniques/sampling
  • Production and Process Controls
  • Terminal Industrial Sterilization
  • FDA inspectional readiness
  • Process validation

Copyright © 2019 Lori A. Carr / All rights reserved.