CEU Credits: 0.1
Course Code: ELM-139
Duration: 60 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
Auditing the Design and Development Process
Audit Tasks 1 and 2
Audit Tasks 3 and 4
Audit Tasks 5 and 6
Audit Task 7
Audit Task 8
Audit Tasks 9 through 12
Audit Task 13
Audit Tasks 14 and 15
Audit Tasks 16 and 17
Auditing the Production and Service Controls Process
Audit Task 1
Audit Task 2
Audit Task 3
Audit Tasks 4 and 5
Audit Task 6
Audit Tasks 7 and 8
Audit Tasks 9 and 10
Audit Tasks 11 and 12
Audit Tasks 13, 14, and 15
Audit Tasks 16, 17, and 18
Audit Tasks 19, 20, and 21
Audit Tasks 22, 23, and 24
Audit Tasks 25, 26, and 27
Audit Tasks 28 and 29
Auditing the Purchasing Process
Audit Task 1
Audit Task 2
Audit Tasks 3, 4, and 5
Audit Tasks 6 and 7
Audit Tasks 8, 9, and 10
Audit Tasks 11 and 12
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