| COURSE OUTLINE
INTRODUCTION 1. Outcomes 2. First Class Pharmaceuticals 3. Introductions 4. New liquids line 5. Definition of validation 6. Equipment qualification 7. Process validation 8. Process control 9. Glossary of terms 10. NA regulations 11. PICS/EU/TGA regulations 12. Summary 13. Review OVERVIEW 14. Introduction 15. History of validation 16. Origins 17. Current trends 18. Applying risk assessment 19. Assessing risk 20. Summary 21. Review WHAT TO VALIDATE? 22. Introduction 23. Developing the scope 24. Other consideration 25. Critical vs non-critical 26. Services and utilities 27. Computerised systems 28. Selecting precess steps 29. Cleaning validation 30. Clearning validation II 31. Laboratory test methods 32. What not to validate? 33. Summary 34. Review STAGES OF VALIDATION 35. Introduction 36. V Model 37. The URS document 38. FAT and SAT 39. Qualification/Commissioning 40. IQ Phase 41. OQ Phase 42. PQ Phase 43. Process validation 44. Validation & SOPs 45. Review of sequences 46. Summary 47. Review DOCUMENTATION 48. Introduction 49. Validation Master plans 50. Protocols and reports 51. Document linkage 52. Documentation flowchart 53. Managing deviations 54. Summary 55. Review CHANGE CONTROL 56. Introduction 57. Importance 58. Types of changes 59. Summary 60. Review |
COURSE OBJECTIVES
Students completing this course should be able to:
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