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LAB 4: IQ and OQ of Lab Equipment
Description: This module covers the requirements for the qualification of laboratory instruments, including IQ, OQ, and PQ. The relationship between vendors, user requirements specifications and qualification are explained. The different approach to simple and complex instruments is addressed, and specifications and calibration requirements for spectrophotometers, chromatographic systems and dissolution apparatus are reviewed.
Price: $239 (AUD)
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(Australian customers, please add GST.)
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COURSE OUTLINE
INTRODUCTION
1. Welcome
2. Overview
3. Assessment
REQUIREMENTS FOR INSTRUMENTS
4. Introduction
5. Useful definitions
6. Instrument calibration
7. Good QC laboratory data
8. Simple vs complex instruments
9. The V model
10. Applying the V model
11. Qualification phase
12. Vendors and IQ support
13. Lab instrument specialist
14. Review
INSTRUMENT QUALIFICATION
15. Introduction
16. Instrument URS
17. Qualification approach
18. Steps for IQ
19. OQ phase
20. HPLC OQ
21. PQ Phase
22. HPLC PQ
23. USP expectations
24. System suitability testing
25. Qualification protocols
26. Documenting protocol execution
27. Summary
28. Review
CALIBRATION PROGRAMS
29. Introduction
30. Calibration and performance checks
31. Scope of calibration
32. Precision and accuracy
33. Calibration rules
34. Instrument identification rules
35. Schedules
36. Calibration and instrument records
37. Review
LABORATORY SOFTWARE QUALIFICATION
38. Introduction
39. Classes of software
40. Examples of laboratory related software
41. Software qualification rules
42. Qualifying spreadsheets
43. Review
CHROMATOGRAPHIC SYSTEMS
44. Introduction
45. HPLC components
46. Typical specifications
47. Column maintenance
48. Mobile phase
49. SST
50. SST acceptance criteria
SPECTROPHOTOMETRIC SYSTEMS
51. Introduction
52. Types of systems
53. Operation principles
54. Typical specifications
55. Calibration tasks
DISSOLUTION APPARATUS
56. Introduction
57. Dissolution apparatus
58. Performance parameters
59. Typical specifications
60. Calibration tasks
INSTRUMENT LOGBOOKS AND EQUIPMENT HISTORY
61. Purpose
62. What to record
CONCLUSION
63. Summary
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COURSE OBJECTIVES
Students completing this course should be able to:
- Describe the steps involved in IQ and OQ of instruments
- State the requirements for software qualification
- List chromatography instrument calibration requirements and frequency
- List chromatography instrument calibration requirements and frequency
- State the GLP expectations for instrument logbooks
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SeerPharma has partnered with GeneEd to now distribute courses in Major Therapeutic Areas, Clinical Research, and Biotechnology & Genetics.
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