MDSAP Country Specific Requirements (USA)
Description:
In previous courses, we focused on providing a high-level overview of each of the process chapters of the Medical Device Single Audit Program (MDSAP). Consequently, the country-specific MDSAP requirements are reviewed separately from these general MDSAP courses. In this course, we will focus on providing a detailed discussion of the United States Food and Drug Administration’s country-specific requirements for the process chapters of MDSAP, as they were not covered in detail in the general MDSAP courses.
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
| MDSAP Audit Model | 1 min 05 sec |
| MDSAP and the USA | 1 min 10 secs |
| Benefits of MDSAP to the USA | 1 min 08 secs |
| USA Regulatory Authorities and MDSAP Exclusions | 1 min 17 secs |
Chapter 1 – Process: Management
| Auditing the Management Process | 1 min 12 secs |
| Audit Task 8 | 1 mins 29 secs |
Chapter 2 – Process: Device Marketing Authorization and Facility Registration
| Auditing the Device Marketing Authorization and Facility Registration Process | 1 min 01 secs |
| Audit Task 1 | 1 min 13 secs |
| Audit Task 2 | 1 min 33 secs |
| Audit Task 3 | 1 min 06 secs |
Chapter 3 – Process: Measurement, Analysis and Improvement
| Auditing the Measurement, Analysis and Improvement Process | 1 min 10 secs |
| Audit Task 1 | 1 min 01 secs |
| Audit Task 12 | 1 min 25 secs |
| Audit Task 12: US FDA-Specific Requirements | 1 min 09 secs |
Chapter 4 – Process: Medical Device Adverse Events and Advisory Notices Reporting
| Auditing the Medical Device Adverse Events and Advisory Notices Reporting Process | 1 min 23 secs |
| Audit Task 1 | 1 min 50 secs |
| Audit Task 2 | 1 min 06 secs |
Chapter 5 – Process: Design and Development
| Auditing the Design and Development Process | 1 min 01 secs |
| Audit Task 4 | 1 min 02 secs |
| Audit Task 5 | 1 min 10 secs |
| Audit Task 8 | 1 min 15 secs |
| Audit Task 13 | 1 min 09 secs |
| Audit Tasks 14 | 1 min 02 secs |
Chapter 6 – Process: Production and Service Controls
| Auditing the Production and Service Controls Process | 1 min 02 secs |
| Audit Task 1 | 1 min 10 secs |
| Audit Task 7 | 1 min 17 secs |
| Audit Task 16 | 1 min 07 secs |
| Audit Task 17 | 1 min 05 secs |
| Audit Task 18 | 1 min 03 secs |
| Audit Task 21 | 1 min 21 secs |
| Audit Task 25 | 1 min 25 secs |
| Audit Task 27 | 1 min 10 secs |
Conclusion
Final Assessment
Certification
Revision History
| Course updated to v2.0 on 4/4/2023 to reflect changes in MDSAP regulations. Added player functionality, policy slide, and version history slide. Added information about CEU's and IACET accreditation | Version 2.0 |
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-143 -
Duration: 60 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes -
version: 2.0 -
Effective Date: 04/04/2023
Reviews:
If you want to understand the specific MDSAP requirements for the USA then this course will explain in detail what they are and how they can be applied.
MDSAP is a complex topic but something that we need to adhere to as an American based medical device manufacturer. This course really makes it easy to follow the exact chapters that we need to know and understand. Great job LAGMP!
Related courses:
Medical Device Single Audit Program (MDSAP) – Part 1
Medical Device Single Audit Program (MDSAP) – Part 2
Medical Device Single Audit Program (MDSAP) – Part 3
Medical Device Single Audit Program (MDSAP) – Chapters 1 to 4
Medical Device Single Audit Program (MDSAP) – Chapters 5 to 7
21 CFR Part 820 Subpart A – General Provisions
21 CFR Part 820 Subpart B – Quality System Requirements
21 CFR Part 820 Subpart C – Design Controls
21 CFR Part 820 Subpart D – Document Controls
21 CFR Part 820 Subpart E – Purchasing Controls
ISO 13485:2016 – Chapter 1-3: Introduction
ISO 13485:2016 – Chapter 5: Management Responsibility
ISO 13485:2016 – Chapter 6: Resource Management
Combination Products (Drugs, Devices and Biologics) – Part 1
Combination Products (Drugs, Devices and Biologics) – Part 2
Combination Products (Drugs, Devices and Biologics) – Part 3
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