SeerPharma Pty Ltd :: DISCover web-based training :: MD-U 2: Quality Systems Requirements

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MD-U 2: Quality Systems Requirements - 21 CFR 820

Description: Implementing a quality system for medical devices can be a complex process. This model will help you to assimilate all the knowledge required in order to implement a quality system in accordance with the 21 CFR 820 regulations.

Price: $179 (AUD)

(Australian customers, please add GST.)

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COURSE OUTLINE

INTRODUCTION
1. Welcome
2. Introduction
3. Reviews and Assessments

QUALITY SYSTEMS
4. Overview of 21 CFR 820
5. Quality System Definition
6. More on Quality Systems
7. QSRs
8. Implementation
9. Quality System Linkages

ROLES AND RESPONSIBILITIES
10. Overview
11. Management
12. Management Representative
13. Company Personnel
14. Review

PRODUCTION ASSURANCE
15. Overview
16. Product Assurance
17. Design Control Overview
18. Design Control
19. Purchasing Control
20. Identification/Traceability
21. Process Control
22. Control of Production Processes
23. Process Validation
24. Device Labeling
25. Handling

QUALITY ASSURANCE
26. Overview
27. Acceptance Activities
28. Nonconforming Products
29. CAPA
30. Servicing and Repair
31. Statistical Techniques
32. Review

PRODUCT DOCUMENTATION
33. Overview
34. Device Master Record
35. Device History Record
36. Complaint Files
37. Review

FDA INSPECTION
38. Introduction
39. Inspection Procedure
40. FDA Inspection Guidance

CONCLUSION
41. Summary

COURSE OBJECTIVES

Students completing this course should be able to:

State how 21 CFR 820 relates to the medical device industry
Identify the requirements of the quality system
Explain the role of key stakeholders in establishing and maintaining a quality system
Identify what documentation is required for quality system

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