MDSAP

Medical Device Single Audit Program (MDSAP) – Part 3

This course will examine the process of preparing and applying for the Medical Device Single Audit Program (MDSAP). It is written from the perspective of the Medical Device company that is considering joining or in the process of joining the program. In addition, an overview of the MDSAP program will be provided, as well as links to more in-depth information on certain topics.

CEU Credits: 0.1

Course Code: ELM-137

Duration: 45 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Introduction

Overview

Learning Objectives

Who Should Take this Course?

Terms Explained

Course Modules

Module 5: MDSAP Roles and Responsibilities During the Audit

Audit Tasks: Audit Model Used by Auditor

When Are Suppliers Involved in MDSAP?

Audit Organizations (AOs) and the Audit

Auditing Organization: Evaluation and Review

Auditing Organization Assessments: Regulatory Assessment

Regulatory Authority Assessor: Enforcement

Appeals to the Regulatory Authorities

Auditing Authority Complaints

Auditing Organizations: Accreditation

Who can become an MDSAP Auditor?

Cost and Training for MDSAP Audit Training

Roles: Regulatory

Roles: Consultancy Organizations

Collaboration with MDSAP Experts

Module 6: Benefits and Future of MDSAP

MDSAP Success Based on Multiple Factors

Overall Benefits of MDSAP Implementation

Manufacturer Benefits of MDSAP Implementation

Advantages for MDSAP Participants

Benefits for Each Country Participant

Future of MDSAP

MDSAP Drawbacks

Challenges of MDSAP Participation

Combating Industry Fears

MDSAP Transition Plan Changes

Conclusion

Final Assessment

Certification

Author

Ginny Ojingwa

Sr. QA Lead III Genzyme

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