Medical Device Single Audit Program (MDSAP) – Chapters 5 to 7

Description:

Upon completion of this course, you will have a comprehensive understanding of the general MDSAP requirements that affect all five MDSAP countries, including the following content from the Audit Model, MDSAP Basics, MDSAP Audit Model, Chapter 5 – Process: Design and Development, Chapter 6 – Process: Production and Service Controls and Chapter 7 – Process: Purchasing.

Curriculum for this course:
Introduction
Overview 1 min 01 secs
Learning Objectives 1 min 31 secs
Who Should Take This Program? 1 min 21 secs
Glossary 1 min 10 secs
MDSAP Basics 1 mins 11 secs
MDSAP Audit Model 1 min 09 secs
Chapter 5 – Process: Design and Development
Auditing the Design and Development Process 1 min 05 sec
Audit Tasks 1 and 2 1 min 45 secs
Audit Tasks 3 and 4 1 min 31 secs
Audit Tasks 5 and 6 1 min 10 secs
Audit Task 7 1 min 48 secs
Audit Task 8 1 min 24 secs
Audit Tasks 9 through 12 1 min 30 secs
Audit Task 13 1 min 09 secs
Audit Tasks 14 and 15 1 min 30 secs
Audit Tasks 16 and 17 1 min 14 secs
Chapter 6 – Process: Production and Service Controls
Auditing the Production and Service Controls Process 1 min 12 secs
Audit Task 1 1 min 55 secs
Audit Task 2 1 min 45 secs
Audit Task 3 1 min 25 secs
Audit Tasks 4 and 5 1 min 10 secs
Audit Task 6 1 min 38 secs
Audit Tasks 7 and 8 1 min 30 secs
Audit Tasks 9 and 10 1 min 39 secs
Audit Tasks 11 and 12 1 min 30 secs
Audit Tasks 13, 14, and 15 1 min 52 secs
Audit Tasks 16, 17, and 18 1 min 22 secs
Audit Tasks 19, 20, and 21 1 min 40 secs
Audit Tasks 22, 23, and 24 1 min 09 secs
Audit Tasks 25, 26, and 27 1 min 18 secs
Audit Tasks 28 and 29 1 min 28 secs
Chapter 7 – Process: Purchasing
Auditing the Purchasing Process 1 min 10 secs
Audit Task 1 1 min 13 secs
Audit Task 2 1 min 20 secs
Audit Tasks 3, 4, and 5 2 min 06 secs
Audit Tasks 6 and 7 1 min 19 secs
Audit Tasks 8, 9, and 10 1 min 27 secs
Audit Tasks 11 and 12 1 min 55 secs
Conclusion
Final Assessment
Certification
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