ISO 13485 Internal Auditor


Course Description
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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.  Topics include:  Audit Fundamentals, Definitions, Purpose, Types, ISO 13485:2003 Requirements, GMP Background and FDA Requirements, Types of Audits – 1st, 2nd & 3rd Party Audits, Definitions of Key Words in ISO 13485 and GMP Standards, Review of Standard Requirements and Summary of Key Points, 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, Corrective Actions/Follow-Up, Defining an Internal Audit Process.

Date(s): Session 1 – February 20 & 21, 2014
Session 2 – June 18 & 19, 2014
Schedule: 8:30 – 4:30
Location: ITBD – 185 Main St., New Britain
Instructor: Joseph DeCarlo
Fee: $495
Contact Hours: 16
Participants: Open to all. Minumum of 5 Participants

Joseph DeCarlo is a senior executive with over 28 years of experience in quality, sales, business development, marketing, and operations. He has helped organizations identify and capitalized on market opportunities to build revenue, presenting over 2500 training & consulting sessions at all levels of an organization. He has implemented and provided consulting support for Quality Management Systems for 100’s of organizations and trained over 15,000 individuals. He is a registered Lead Auditor with the RABQSA and a past chairman of the ASQ.  He has lectured at Harvard University, Northeastern University, Columbia University, CCSU and Fordham University.

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