Institute of Technology & Business Development

Institute of Technology & Business Development

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ISO 13485 Internal Auditor Training

This course covers the fundamentals of auditing and specific techniques thereof. Included will be review and interpretation of the ISO 13485:2003 standard as well as application of techniques during audit scenarios. Content Outline:

  • Audit Fundamentals
  • Definitions, purpose, types
  • ISO 13485:2003 requirements
  • GMP background and FDA requirements
  • What is auditing.
  • Types of audits – 1st, 2nd & 3rd party audits?
  • 3rd party auditing process and certification requirements
  • Definitions of key words in ISO 13485 and GMP Standards
  • Review of Standard Requirements and Summary of Key Points
  • General requirements
  • Changes from old Standard and newly emphasized points
  • General review of 5 major categories
  • Quality Management System
  • Management Responsibility
  • Resource Management
  • Product Realization
  • Measurement, Analysis and Improvement
  • Type of Findings
  • Minor non-compliances
  • Major non-compliances
  • Recommendations
  • Corrective actions/follow-up
  • Defining an Internal audit process

Registration Form

Date: September 22 and 23, 2016

Schedule: 8:30am-4:30pm

Location: Downtown Campus, 185 Main Street, New Britain, CT 06051

Cost: $695

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