SeerPharma Pty Ltd :: DISCover web-based training :: VAL 9: Computer Systems Validation Part I

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VAL 9: Computer Systems Validation Part I

Description: An introduction to the international regulations and principles behind Computer Systems Validation.

Price: $259 (AUD)

(Australian customers, please add GST.)

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COURSE OUTLINE

INTRODUCTION
1. Outcomes
2. First Class Pharmaceutical
3. Meet the V team
4. Introduction
5. Validation project
6. Definition I
7. Definition II
8. What requires validation?
9. Review I
10. Benefits
11. Qualification
12. Risk Management
13. Industry guidelines
14. GAMP categories
15. Review II
16. Summary
17. Review II

PLANNING PHASE
18. Introduction
19. Computer Systems Lifecycle
20. Planning Phase
21. URS
22. Traceability matrix

VALIDATION STRATEGY AND PLAN
23. Validation strategy
24. Regulation assessment
25. ERES I
26. ERES II
27. ERES assessment
28. Supplier audits
29. Audit questionnaire
30. Risk assessment
31. Risk management
32. Selecting a strategy I
33. Selecting a strategy II
34. Validation plan
35. Change management
36. Summary
37. Review

CONCLUSION
38. Summary

COURSE OBJECTIVES

Students completing this course should be able to:

Define some important computer systems validation terms
List the benefits of performing computer systems validation
Describe the planning phases in the Computer Systems Lifecycle

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