SeerPharma Pty Ltd :: DISCover web-based training :: VAL 3: Commissioning and Installation Qualification

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VAL 3: Commissioning and Installation Qualification

Description: An introduction to the international regulations and principles behind Commissioning and Installation Qualification.

Price: $259 (AUD)

(Australian customers, please add GST.)

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COURSE OUTLINE

OUTCOMES
1. Introduction
2. First Class Pharmaceuticals
3. Meet the V Team
4. The new line
5. Regulatory definitions
6. Guidance docuements
7. V model approach
8. Summary

DEFINITIONS
9. Introduction
10. Common interfaces
11. Commissioning/IQ timeline
12. Purpose of commissioning
13. Purpose of IQ
14. Comparisons
15. Review I
16. FAT and SAT
17. Responsibilities
18. Vendor Responsibilities
19. Commissioning reports
20. Summary
21. Review II

IMPACT ASSESSMENTS
22. Introduction
23. Levels of impact
24. System boundaries I
25. System boundaries II
26. The impact assessment
27. Criticality assessment
28. Determining criticality
29. Assessment flowchart
30. Review I
31. The scope of activity
32. Summary
33. Review II

SCOPE OF IQ
34. Introduction
35. Essential IQ items
36. Test requirements
37. Calibration requirements
38. Review I
39. Summary
40. Review II

IQ PROTOCOLS
41. Introduction
42. Approval of IQ report
43. Conducting the IQ
44. Documentation
45. Summary
46. Review

CONCLUSION
47. Summary

COURSE OBJECTIVES

Students completing this course should be able to:

Define installation qualification and commissioning activities
Explain the difference between qualification and commissioning
Determine qualification requirements based on an impact/risk assessment
State and explain the scope and responsibilities of IQ
Prepare and execute an IQ protocol
Prepare and approve an IQ report

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