| Axeon Corporation » eCourses » Live Online Courses » 4-day ISO 13485:2016 Lead Auditor- Exemplar Global Certified- with FDA 21 CFR 820

Price: $1945.00
This training meets 4 times.Mon, Mar 14, 2016 7:30 AM – 4:30 PM MDT
Tue, Mar 15, 2016 7:30 AM – 4:30 PM MDT
Wed, Mar 16, 2016 7:30 AM – 4:30 PM MDT
Thu, Mar 17, 2016 7:30 AM – 4:30 PM MDT
Mon, Apr 4, 2016 7:30 AM – 6:30 PM MDT

QUALITY MEDICAL DEVICE MANAGEMENT SYSTEMS LEAD AUDITOR
WITH ISO 13485:2016 AND FDA 21 CFR 820

We teach you how to use auditing to improve your organization

Each 4-day class covers:

 Quality management principles
 Standards and guidelines (including history of standards)
 Interpretation of the latest revision ISO 9001
 Interpretation of the latest revision ISO 13485
 FDA 21 CFR 820
 Documentation and records
 Introduction to quality audit
 Managing the audit process
 Audit scheduling and preparation
 Performing the audit
 Reporting the audit
 Corrective action and follow-up
 Registration, Accreditation and Auditor Certification
The workshops include:
 Analyzing Processes to Identify Resources and Critical Controls
 Analyzing Operational Risk
 Reviewing System Documentation and Preparing an Audit Plan
 Reviewing Processes and Preparing Checklists
 Verifying Facts
 Determining Nonconformities
 Writing Nonconformity Statements
 Interviewing Auditees
 Chairing a Closing Meeting
 Reporting the Audit
 Taking Corrective Action

Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these EXEMPLAR GLOBAL knowledge competency units: MD – Medical Device Management Systems, AU – Auditing Management Systems and TL – Leading Management Systems Audit Teams. The Certificate of Attainment provides evidence of knowledge competency defined by EXEMPLAR GLOBAL for certification as a Medical Device Management Systems Lead Auditor.
Even though ISO 9001 and ISO 13485 are used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard.

This course is being held in conjunction with Quality Management International, Inc. (QMII) an Exemplar Global certified provider.

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