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Medical Device Single Audit Program (MDSAP) Internal Auditor Training

Designed especially for experienced auditors, this intensive MDSAP class will teach you how to apply the process approach and align your current internal audit program to the MDSAP requirements. We also take a detailed look at country-specific requirements for the five MDSAP-participant markets: Australia, Brazil, Canada, Japan, and the United States. Upon completion of this class, participants can choose to earn an exam-based certificate that can be used as independent evidence of your training and qualification to maintain MDSAP compliance. Not an auditor? Check out this MDSAP overview class instead. 

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Brief Overview of This MDSAP Internal Auditor Training Class

SkillsLab Class ?

Class Content

In-Depth

Class Duration

5 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person

Certification of Completion

Yes

Continuing Education Units (CEUs)

2.8

* SkillsLab classes delivered in-person are full-day sessions delivered over 4 consecutive days.

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming Medical Device Single Audit Program Internal Auditing Classes

SkillsLab $3295

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
AMF VIRTUAL DELIVERY (Eastern time - PM) 15 Jul 2024 19 Jul 2024 1:00PM - 5:00PM Eastern US Time Virtual REGISTER
AMF VIRTUAL DELIVERY (Eastern time - PM) 28 Oct 2024 01 Nov 2024 1:00PM - 5:00PM Eastern US Time Virtual REGISTER

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Intensive MDSAP Auditor Course

The purpose of this course is to apply the process-based approach in aligning an organization’s internal audit program to the Medical Device Single Audit Program (MDSAP) requirements, including details and practice in additional country-specific requirements for Australia, Brazil, Canada, Japan, and the United States. Upon successful completion of the examination, participants will earn a numbered certificate and eligibility to participate in the Exemplar Global auditor certification scheme.  

Course Overview
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MDSAP Overview

  • MDSAP goals, participants, execution
  • MDSAP structure, processes, outcomes, tasks, and linkages
  • Using the MDSAP Audit Approach document
  • Nonconformity grading
Exercise! Practice Nonconformity Grading
Exercise! MDSAP Linkages and Structure

MDSAP Audit Approach

  • MDSAP as a system audit and process approach
  • Risk-based approach for indirect / direct clauses
  • Control of quality management system (QMS) processes
Case Study! OurTeam Introduction

Regulations Overview

  • MDSAP as a regulatory compliance audit
  • Device regulations in MDSAP jurisdictions
  • Analyze different jurisdictional approaches to device makers

ISO 13485:2016 Review

  • ISO 13485:2016 – Introduction, scope, and definitions
  • ISO 13485:2016 clauses: Intent and guidance

Management Process (MDSAP Chapter 1)

  • Process outcomes, tasks, and linkages
  • Country-specific requirements
Exercise! Building an Audit Checklist
Case Study! Internal Audit (Part 1)

Device Marketing Authorization and Facility Registration Process (MDSAP Chapter 2)

  • Process outcomes, tasks, and linkages
  • Country-specific requirements
Case Study! Internal Audit (Part 2)

Measurement, Analysis and Improvement Process (MDSAP Chapter 3)

  • Process outcomes, tasks, and linkages
  • Country-specific requirements
Exercise! Building an Audit Checklist
Case Study! Internal Audit (Part 3)

Medical Device Adverse Events and Advisory Notices Reporting Process (MDSAP Chapter 4)

  • Process outcomes, tasks, and linkages
  • Country-specific requirements
  • Use of Annex 3 – Medical Device Adverse Events and Advisory Notices Reporting Process Quick Reference
Case Study! Internal Audit (Part 4)

Design and Development Process (MDSAP Chapter 5)

  • Process outcomes, tasks, and linkages
  • Country-specific requirements
Case Study! Internal Audit (Part 5)

Purchasing Process (MDSAP Chapter 6)

  • Process outcomes, tasks, and linkages
  • Country-specific requirements
Exercise! Building an Audit Checklist
Case Study! Internal Audit (Part 6)

Production and Service Controls Process (MDSAP Chapter 7)

  • Process outcomes, tasks, and linkages
  • Country-specific requirements
Case Study! Internal Audit (Part 7)

Annex Topics

  • Auditing technical documentation (Annex 1)
    1. Using MDSAP as a product audit
    2. Selecting a product for review
    3. Determining auditing expectations
    4. Evaluating the technical process and technical documentation
  • Auditing sterilization processes (Annex 2)
    1. Using MDSAP as a process audit
    2. Applying a holistic approach to sterilization processes
  • Auditing written agreements (Annex 4)
  • MDSAP exclusions (Annex 6)

Internal Audit Program Management

  • Effective internal auditing programs
  • Apply a risk-based approach to the internal auditing program
  • Strategies to align the internal audit program with the process approach and MDSAP
  • Evaluate sample tactics and tools for aligning the program to MDSAP
  • OurTeam Internal Audit procedure
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
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Review MDSAP processes, tasks, outcomes, linkages, and nonconformity grading. 

Review ISO 13485:2016 intent and guidance.

Analyze device regulations in MDSAP jurisdictions.

Identify requirements for auditing technical documentation, sterilization processes, and written agreements. 

Evaluate objective evidence using a case study approach to simulate an internal audit to MDSAP.

Apply a risk-based approach to designing the internal audit program.

Evaluate strategies and recommendations for aligning the internal audit program to MDSAP.

Who Should Attend

Who Should Attend

This is an advanced auditing course and participants are expected to have practical experience in internal auditing and a working knowledge of ISO 13485:2016. If you do not yet have much hands-on experience with QMS auditing, we recommend first taking our ISO 13485:2016 lead auditor or ISO 13485:2016 internal auditor training class.

  • Internal Auditors
  • RA/QA Professionals
  • Advanced Auditors
  • QMS Professionals
  • Supplier Auditors

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