SeerPharma Pty Ltd :: DISCover web-based training :: VAL 10: Computer Systems Validation Part II

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VAL 10: Computer Systems Validation Part II

Description: Builds on VAL 9 (Computer Systems Validation Part I). An introduction to computer systems validation as required by GxP regulations.

Price: $259 (AUD)

(Australian customers, please add GST.)

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COURSE OUTLINE

INTRODUCTION
1. Outcomes
2. First Class Pharmaceuticals
3. Introduction
4. The validation project
5. Computer Systems Lifecycle

DESIGN/DEVELOP/INSTALL
6. Introduction
7. Deliverables.
8. Design specifications
9. Development testing
10. Test plans
11. Test cases and scripts
12. Good testing practices
13. Test documents
14. Change management
15. Summary
16. Review

VALIDATION PHASE
17. Introduction
18. Deliverables
19. Computerised systems
20. Timeline
21. Platform qualification
22. Application IQ
23. OQ
24. PQ
25. Change Management
26. Validation report
27. Test scripts
28. Summary
29. Review

OPERATIONS/MAINTENANCE PHASE
30. Introduction
31. Deliverables
32. Operational lifecycle
33. Change control
34. Summary
35. Review

LEGACY SYSTEMS
36. Introduction
37. Legacy systems
38. Retrospective validation
39. Summary
40. Review
41. Conclusion
42. Summary

COURSE OBJECTIVES

Students completing this course should be able to:

Describe each of the phases in the Computer Systems Lifeycle
Describe which systems to validate
Determine the amount of validation required, and the strategy to use
Describe legacy systems and how to perform retrospective validation

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