SeerPharma Pty Ltd :: DISCover web-based training :: MD-A 1: Australian Regulatory Affairs Overview

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MD-A 1: Australian Regulatory Affairs Overview

Description: An overview of Australian regulatory affairs.

Price: $179 (AUD)

(Australian customers, please add GST.)

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COURSE OUTLINE

INTRODUCTION
1. Welcome
2. Overview
3. Assessment

AUSTRALIAN REGULATIONS
4. Medical Device Industry
5. Historical Perspective

THE ESSENTIAL PRINCIPLES
6. Introduction
7. the Essential Principles Checklist
8. Specific Essential Principles
9. Applying the Essential Principles
10. Review

ROLES
11. Introduction
12. Manufacturer Responsibilities
13. Sponsor Responsibilities
14. TGA Responsibilities
15. Review

CLASSIFICATION AND CONFORMITY
16. Medical Device Classification
17. Conformity Assessment
18. Review

CONCLUSION
19. Summary

COURSE OBJECTIVES

Students completing this course should be able to:

Identify the Essential Principles
Define the roles of the sponsor, manufacturer, and regulator
Describe the classification systems of medical devices

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