ISO 13485:2016 FDA Regulated Industries Lead Auditor - Exemplar Global Certified
Duration: 5 Days = 4.0 CEUs
List PriceIn-House Training
$2,095.00Call for Quote

DateCityVenueRegister
November 13-17, 2017Hartford - CT - USVenue to be confirmed.REGISTER ONLINE NOW
April 16-20, 2018Nashville - TN - USVenue to be confirmed.REGISTER ONLINE NOW
April 16-20, 2018Boston - MA - USVenue to be confirmed.REGISTER ONLINE NOW

SAI Global is an Exemplar Global certified TPECS provider. This course meets the knowledge examination requirements of the Medical Devices Quality Management Systems (MD) certification scheme.

Learn the necessary skills and activities required to successfully lead a team of auditors to perform effective third-party audits of an organization’s quality management system against ISO 13485:2016 Medical Devices.

This highly participative course is presented by SAI Global’s instructors, each of whom have decades of experience in the medical devices industry and extensive experience conducting and leading audits in FDA regulated industries.

This course is based on quality management systems ISO 9001 and ISO 13485 along with FDA QSR 21CFR820 (current Good Manufacturing Practices), ISO 14971 Risk Management, and Medical Device Directive 93/42 EEC.

To register for the ISO 13485 FDA Regulated Auditor Lead Auditor Exemplar Global Certified course, please contact us today.

Course Objectives

This 5 day course is designed to provide participants with an understanding of quality management principles and reference is made to various national and international standards including quality management systems ISO 9001 and ISO 13485 along with FDA QSR 21CFR820 (current Good Manufacturing Practices), ISO 14971 Risk Management, and Medical Device Directive 93/42 EEC. This theoretical background is developed by the use of practical activities on auditing systems and techniques, thus providing an opportunity for individual participants to practice their skills during simulated assessment.

Prerequisites

  • Studying the current published version of ISO 13485:2016 and ISO 9001:2015 prior to attending this course is recommended

Who Should Attend?

  • R&D managers/engineers

  • RA/QA managers/engineers

  • Management representatives

  • Individuals who want to become Exemplar Global Certified Lead Auditors

  • Individuals leading their companies to registration

  • Product, project, program managers

  • Internal auditors

Key Session Topics

  • Module 1: Quality Management Systems

  • Module 2: Audit Basics Overview

  • Module 3: Quality Management Standards

  • Module 4: Documented Systems

  • Module 5: Audit Planning

  • Module 6: Audit Work Documents

  • Module 7: Opening Meeting

  • Module 8: Audit Techniques

  • Module 9: Nonconformity Writing

  • Module 10: Closing Meeting

  • Module 11: Post Audit Activity

  • Module 12: 1st, 2nd, 3rd-Party Audits – A Perspective

Course Outline

At the end of the course, participants will have obtained a sound appreciation of:
  • How to perform an effective management system audit

  • How quality systems and regulatory requirements relate to the business management system

  • How to construct an audit program and checklists

  • Evaluation of the business impact of audit findings

  • Communication skills in the presentation of audit findings

  • Business improvement through the use of corrective and preventive action programs

Certification


SAI Global is an Exemplar Global certified TPECS provider. This course meets the knowledge examination requirements of the Medical Devices Quality Management Systems (MD) certification scheme.

Attendees who successfully demonstrate competence during this course will receive a Certificate of Attainment for the following knowledge competency units:
  • Exemplar Global - MD - Medical Devices Quality Management Systems

  • Exemplar Global - AU - Management systems auditing

  • Exemplar Global - TL - Leading management systems audit teams


Please note: Additional experience/qualification requirements must be met to achieve certification as an auditor. These are provided through Exemplar Global. Additional information can be found at http://exemplarglobal.org.


How to Register

  • Online: Click the "Register Online Now" link to access the online registration form and pay by credit card.
  • Call: USA: 1-800-374-3818, CANADA: 1-877-426-0714. Group Bookings available!
  • Email: Training.Americas@saiglobal.com.