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MEDICAL DEVICES
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US FDA QSIT AND CAPA
REQUIREMENTS FOR
MEDICAL DEVICES

DOES YOUR QMS AND CAPA PROCESS MEASURE UP TO FDA
EXPECTATIONS?

Conference Date: 02-03 Oct 2008
Conference Ref: N10-8108
Fee: £1100 + VAT
Venue: Harrington Hall Hotel, London

BENEFITS IN ATTENDING:

  • Ensure your company is compliant with FDA requirements:-
  • Clarify FDA’s current focus
  • Understand FDA Quality System Regulation (CGMPs)
  • Discover how to prepare your company for FDA Inspections
  • Know how to respond to 483’s and Warning Letters
  • Take away practical tools and tips to improve your companies CAPA process
  • Understand how to use a risk based approach to initiating and monitoring CAPAs