ISO 13485:2016 Internal Auditor

This course covers the fundamentals of auditing and specific techniques thereof. Included will be review and interpretation of the ISO 13485:2016 Standard as well as application of techniques during audit scenarios.

Content Outline:

• Audit Fundamentals
• Definitions, purpose, types
• ISO 13485:2016 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
• Internal audit process

Anyone interested in this topic.  There are no prerequisites required.

Very well presented.

CCSU Downtown Campus, 185 Main Street, New Britain, CT 06051

Wednesday & Thursday

March 24 & 25

8:30 am – 4:30 pm

$700

Contact:  Christa Sterling; csterling@ccsu.edu; 860-832-2277

If you are a CT manufacturing company with less than 2,000 employees, not receiving other funding, you may qualify for 50% funding by the CT Dept. of Labor for eligible classes.  Complete the DOL Form and email to csterling@ccsu.edu for approval prior to registering.

Mr. Joseph DeCarlo

Joseph DeCarlo is a senior executive with over 30 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.