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
Revision History
| 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:
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General Info:
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CEU Credits: 0.1 -
Course code: ELM-139 -
Duration: 60 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes -
version: 2.0 -
Effective Date: 04/04/2023
Reviews:
An excellent way to understand a complex topic. I really loved the on-screen references to the audit tasks, super helpful!
Learnaboutgmp’s training has proved to be an invaluable tool in our training arsenal, yet again another great course to help us train our workforce.
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