Boston Professional Events List


3 Hour Webinar: How the FDA is Trained on Medical Device Inspections


Date
Oct 16, 2017 - 01:00 PM
Organizer
wcsseminars
Venue
Onlinewebinar
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4, Hollywood, FL 33021,

Hollywood,
FLORIDA,
United States,
ZIP: 33021
Phone: 347 282-5400

FDA Field Inspectors conduct administrative and enforcement activities related to the Quality System (QS) Regulation (21 CFR 820), the Medical Device Reporting (MDR) Regulation (21 CFR 803), the Medical Device Tracking Regulation (21 CFR 821), the Corrections & Removals Regulation (21 CFR 806), and the Registration & Listing Regulation (21 CFR 807).
Under the QS regulation, manufacturers are expected to control their devices from design stage through postmarket surveillance. Manufacturing processes, such as sterilization, are required to be implemented under appropriate controls. The MDR, Tracking, and Corrections and Removals regulations involve activities with which manufacturers and importers are required to comply after the devices are distributed.
Before inspectors can conduct the above inspections, they are trained by the FDA on how to conduct inspections. This training program encompases the five regulations for inspecting medical device firms.
 
Areas Covered

 

I. Background
    A. The Quality System (QS) Regulation
    B. The MDR Regulation
    C. The Medical Device Tracking Regulation
    D. The Corrections and Removals Regulation
    E. The Registration and Listing Regulation

Who will Benefit
  • Quality Managers
  • Quality Engineers
  • Regulatory Affairs
  • Small business owners
  • GxP


Speaker Details


Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Turnarounds and Business Development. 

Event Categories
Keywords: FD




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