MDSAP

MDSAP Country Specific Requirements (Japan)

In this course, we will focus on providing a detailed discussion of Japan’s Ministry of Health, Labour and Welfare (MHLW) and their country-specific requirements for the process chapters of MDSAP, as they were not covered in detail in the general MDSAP courses.

CEU Credits: 0.1
Course Code: ELM-144
Duration: 45 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V2.0
Effective Date: 04/04/2023

Curriculum for this course

Overview
Learning Objectives
Who Should Take This Program?
Glossary
MDSAP Basics
MDSAP Audit Model
Benefits of MDSAP to Japan
Auditing the Management Process
Audit Task 8
Auditing the Device Marketing Authorization and Facility Registration Process
Audit Task 1
Audit Task 2
Audit Task 3
Auditing the Measurement, Analysis and Improvement Process
Audit Task 7
Audit Task 12
Auditing the Medical Device Adverse Events and Advisory Notices Reporting Process
Audit Task 1
Audit Task 2
Auditing the Design and Development Process
Audit Task 1
Audit Task 13
Auditing the Purchasing Process
Audit Task 5

Conclusion

Final Assessment

Certification

Course updated to v2.0 on 04/04/2023 to reflect FDA update to MDSAP Audit Approach policy document MDSAP AU P0002.008 including changes to: Audit sequence, management process, measurement analysis and improvement process, medical device adverse events and advisory notices reporting, design and development process and production and service controls
Version 2.0

Author

Ginny Ojingwa

Sr. QA Lead III Genzyme

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