GLP Quality Control: IQ/OQ and Calibration of Lab Equipment

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Program/Course ID: GLPQ02 Enrollment Period: 12 months. Average Learning Time: ~. Additional Resources: Supplemental materials/activities. Credit Hours: 3 credits. Method of Training: Online, asynchronous, self-paced eLearning. Accessibility: 24/7 access to all program materials. Demonstration: Four (4) free trial courses are available. Group/Employee Training: Click here to request a quote. Final Assessment: Multiple choice; unlimited attempts. Certificate: Encrypted PDF with validation QR barcode.

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2024 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.

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Outline: QC REGULATIONS AND QUALIFICATION 1. Introduction 2. Instrument calibration 3. Useful definitions 4. Good QC laboratory data 5. The V model 6. Applying the V model 7. Simple vs complex instruments 8. Qualification phases 9. Vendors 10. Lab instrument specialist 11. Review INSTRUMENT QUALIFICATION 12. Introduction 13. Instrument URS 14. Qualification approach 15. Steps of Installation Qualification (IQ) 16. IQ: USP definition 17. Operational Qualification (OQ) Phase 18. OQ: USP definition 19. HPLC OQ 20. Performance Qualification (PQ) Phase 21. HPLC PQ 22. PQ: USP definition 23. System suitability testing 24. SST acceptance criteria 25. Qualification protocols 26. Protocol execution 27. Summary 28. Review CALIBRATION RECORDS 29. Introduction 30. Calibration and performance checks 31. Precision and accuracy 32. GLP identification rules 33. Scope of calibration 34. Calibration rules 35. Schedules 36. Calibration records 37. Review LABORATORY SOFTWARE QUALIFICATION 38. Introduction 39. Classes of software 40. Software qualification rules 41. Software examples 42. Qualifying spreadsheets 43. Review I 44. Review II CHROMATOGRAPHIC SYSTEMS 45. Introduction 46. HPLC/GC 47. HPLC components 48. Typical specifications 49. Column maintenance 50. Mobile phase 51. SST SPECTROPHOTOMETRIC SYSTEMS 52. Introduction 53. Types of systems 54. Operation principles 55. Typical specifications 56. Cell specifications 57. Calibration tasks I 58. Calibration tasks II DISSOLUTION APPARATUS 59. Introduction 60. Dissolution apparatus 61. Performance parameters 62. Typical specifications 63. Calibration tasks 64. Review INSTRUMENT LOGBOOKS AND EQUIPMENT HISTORY 65. Introduction 66. Purpose 67. What to record 68. Review CONCLUSION 69. Summary		Objectives:

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Comments: For quotes or invoices please provide the course(s) and number of students.	GLP Quality Control: IQ/OQ and Calibration of Lab Equipment