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