Medical Device Single Audit Program (MDSAP) – Part 1
Description:
This course will examine the process of preparing and applying for the Medical Device Single Audit Program (MDSAP). It is written from the perspective of the Medical Device company that is considering joining or in the process of joining the program. In addition, an overview of the MDSAP program will be provided, as well as links to more in-depth information on certain topics.
Curriculum for this course:
Introduction
| Overview | 45 secs |
| Learning objectives | 1 min |
| Who should take this course? | 30 secs |
| Terms explained | 1 min 15 secs |
| Course modules | 35 sec |
Module 1: Introduction to MDSAP
| What is MDSAP? | 43 secs |
| International regulators: IMDRF | 55 secs |
| Parties involved in MDSAP and MDSAP pilot creation | 48 secs |
| International medical device regulators forum (IMDRF) | 49 secs |
| History of IMDRF | 51 secs |
| IMDRF and MDSAP requirements/documentation | 1 min 02 secs |
| The purpose of the MDSAP pilot | 1 min 10 secs |
| The MDSAP pilot timeline | 58 secs |
| The MDSAP timeline | 44 secs |
| MDSAP pilot program participating countries | 39 secs |
| International regulatory authorities participation | 50 secs |
| Observers of the MDSAP pilot and program | 1 min 01 sec |
| MDSAP – Roles of participants and observers | 57 secs |
| Pilot MDSAP “Criteria for Success” | 1 min 10 secs |
| How the MDSAP pilot audit was conducted | 51 secs |
| MDSAP pilot grading system | 39 secs |
| MDSAP Pilot: Mid-pilot status report | 45 secs |
| MDSAP Pilot: List of auditing organization participants | 1 min 30 secs |
| Expected improvements from implementing MDSAP pilot program audit model | 1 min 07 secs |
| Benefits of the “All-in-One” audit model | 59 secs |
| Manufacturers’ benefits of participating in MDSAP pilot | 1 min 22 secs |
| MDSAP pilot goals and future MDSAP use | 43 secs |
| MDSAP pilot audit model online | 1 min 11 secs |
| FDA site specific online information/forms | 55 secs |
| MDSAP online policies, procedures, templates and forms | 1 min 15 secs |
| MDSAP FDA and ANSA question and answer site | 50 secs |
| MDSAP document for audit assessment | 1 min 10 secs |
Module 2: The MDSAP Audit Model Overview
| MDSAP objective | 1 min 09 sec |
| About MDSAP objectives | 58 secs |
| MDSAP certificate | 59 secs |
| The MDSAP equals one audit for five countries | 1 min 05 sec |
| International participation and exclusions | 49 secs |
| MDSAP International and US participation | 1 min 15 sec |
| Manufacturers exceptions for inclusion in MDSAP: Electronic product radiation control | 51 secs |
| MDSAP audit plan has mapped requirements | 1 min 23 sec |
| MDSAP audit model structure | 48 secs |
| MDSAP Effectiveness: External factors | 55 secs |
| MDSAP impact on ISO 13485:2016 | 1 min 10 sec |
| ISO 13485 versions | 55 secs |
| ISO 13485:2016 alignment with MDSAP | 59 secs |
| MDSAP audit general focus | 55 secs |
| The MDSAP audit-process approach | 1 min 30 sec |
| MDSAP Audit Roadmap: Seven process chapters | 1 min 15 sec |
| MDSAP sequence and interrelationships | 1 min 18 sec |
| Process Linkages (Interrelationships): audit model | 1 min 23 sec |
| MDSAP Audit Structure: Seven processes | 1 min 55 sec |
| Audit Model-FDA document P002 and companion document online | 48 secs |
Conclusion
Final Assessment
Certification
Author:
General Info:
-
CEU Credits: 0.1 -
Course code: ELM-135 -
Duration: 45 mins -
Skill Level: Basic -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
For a global organization like us this course was invaluable to identify the key differences between the regulations from the various jurisdictions involved in MDSAP.
This is a great way to learn about the key points of the MDSAP approach.
As an audit in a medical device firm this course helped me identify the key Quality Systems requirements necessary for success in the MDSAP audit.
If you want to learn about the steps necessary to prepare for a MDSAP audit this is the course for you.
Related courses:
How to Prepare for Internal & External Laboratory Audits
How to Perform Supplier Qualification
21 CFR Part 820 Subpart B – Quality System Requirements
FDA Inspection Readiness – Part 1
FDA Inspection Readiness – Part 2
FDA Inspection Readiness – Part 3
21 CFR Part 820 Subpart C – Design Controls
21 CFR Part 820 Subpart D – Document Controls
21 CFR Part 820 Subpart E – Purchasing Controls
21 CFR Part 820 Subpart F – Identification and Traceability
21 CFR Part 820 Subpart G – Production and Process Controls
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