| |
|
|
|
MD-Q 1: Managing a Quality Management System (QMS)
Description: In this module, you will learn about the requirements and maintenance of a Quality Management System (QMS).
Price: $209 (AUD)
|
 |
(Australian customers, please add GST.)
Note: We use 128-bit SSL security encryption on all webpages where private information is taken.
Terms and conditions
|
|
COURSE OUTLINE
INTRODUCTION
1. Welcome
2. Introduction
3. Reviews and assessments
QUALITY MANAGEMENT SYSTEM OVERVIEW
4. Overview
5. Key QMS subsystems within ISO13485
6. Key QMS subsystems within CFR820
7. Regulatory requirements
8. Maintenance of a QMS
9. Topic review
MANAGEMENT RESPONSIBILITY
10. Overview
11. Management compliance responsibility
12. Periodic management review
13. Overview of QMS roles and responsibilities
14. Management responsibilities
15. The management representative
16. Topic review
QUALITY AUDITS
17. The role of audits in a QMS
18. Setting up an internal audit program
19. Key requirements for internal audits
20. The five steps of internal audits
21. Commitment tracking
22. Topic review
MEASURING PERFORMANCE
23.
Overview
24. Monitoring and measurement
25. Sources of data
26. Statistical techniques
27. Improvement
28. Topic review
CONCLUSION
29.
Summary
|
|
COURSE OBJECTIVES
Students completing this course should be able to:
- List the key characteristics of a QMS
- State the responsibilities of quality management roles
- Describe the elements of a quality audit program
- Relate how the internal audit affects management role in the QMS
- Recognise the importance of measuring performance
|
|
|
|
SeerPharma has partnered with GeneEd to now distribute courses in Major Therapeutic Areas, Clinical Research, and Biotechnology & Genetics.
|
|
