SeerPharma Pty Ltd :: DISCover web-based training :: IS/IT 1: Introduction to IS/IT Compliance

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IS/IT 1: Introduction to IS/IT Compliance

Description: Companies today are heavily reliant on IT services. Therefore, the IT departments within companies must comply with regulations. This module introduces you to the applicable regulations and how they affect IT.

Price: $259 (AUD)

(Australian customers, please add GST.)

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COURSE OUTLINE

INTRODUCTION TO REGULATIONS
1. Introduction
2. First Class Pharmaceuticals
3. What Is Compliance?
4. Regulations Overview
5. Disasters in Reporting
6. How Regulations Came About
7. The IT Perspective
8. Headlines
9. Working in a Regulated Industry
10. How Regulations Affect IT
11. What Is IT Compliance?
12. Ramifications
13. Scope of the Audit
14. Computerized Systems
15. Review

REGULATIONS IN DETAIL
16. Regulations in Detail
17. Introduction
18. Who Are the Regulators?
19. Policies and Procedures
20. Regulations
21. What Is GxP?
22. What Is GMP?
23. GMP in Different Countries
24. US Regulations
25. What Is 21 CFR Part 11?
26. HIPAA
27. SOX
28. Review I
29. Regulatory Guidelines I
30. Regulatory Guidelines II
31. Best Practice Guidelines 1
32. Best Practice Guidelines II
33. Review

MEETING LEGAL OBLIGATIONS
34. Introduction
35. Outcomes of Non-compliance
36. Meeting Regulations
37. IT Compliance Policies and Procedures
38. Example
39. Global Policies and Procedures
40. Activity
41. Review

MANAGING COMPLIANCE REGIONALLY
42. Introduction
43. Issues Managing Compliance
44. Company Policies and Procedures
45. Issues Managing Multi-Site Systems
46. System Management Model
47. Review

CONCLUSION
48. Summary

COURSE OBJECTIVES

Students completing this course should be able to:

Recognise the regulations that affect the life sciences industry
Recognise the impact these relations have on IT
Identify the common IT features of these regulations
State the role of regulations and guidelines
Recognise the compliance issues to be managed in multi-site companies

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