Device Changes and the 510(k) - Webinar By GlobalCompliancePanel 2012

  • 09 May 2012
  • Webinar

Description

Topics
  • FDA`s and EU`s emphasis
  • U.S. FDA device clearance / approval
  • Tracking and evaluating changes – the "tipping point"
  • Product changes and filing a new 510(k) – who`s responsible
  • K-97-1 and the FDA`s "Decision Tree"
  • Is the process "risk based"?
  • Resolving a "wrong decision"
  • Documenting the process / rationale
Who should Attend
  • Regulatory Affairs
  • Senior Management, Project Leaders, Internal / External Consultants
  • R&D and Engineering Staff
  • Quality Systems Personnel / QAE
  • New product development, regulatory submissions, driving company-wide quality initiatives, under a risk-justified approach
  • Personnel involved in Lean and Six Sigma Initiatives
  • CAPA personnel desiring to minimize post-production / life cycle, root cause investigation, and other costly problems

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Important

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Event Categories

Health & Medicine: Healthcare, Hospitals & Clinics, Medical device, Pharma

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