| COURSE OUTLINE
INTRODUCTION 1. Outcomes 2. Meet the V team 3. Introduction 4. Worst-case scenario 5. The new line 6. Definitions 7. Review I 8. Summary 9. Review II SCOPE 10. Introduction 11. Two approaches 12. SOP validation 13. SOP requirements 14. Classifying equipment 15. What to validate I 16. What to validate II 17. Common equipment 18. Bracketing 19. Cleaning requirements 20. CIP qualification 21. Using previous data 22. Testing surface residues 23. Microbial limits and residues 24. Summary 25. Review PRE-REQUISITES 26. Analytical techniques 27. LOD and LOQ 28. Swab recovery studies I 29. Swab recovery studies II 30. Visual inspection 31. Role of flush sampling 32. Summary 33. Review ACCEPTANCE CRITERIA 34. Introduction 35. How clean is clean? 36. Worst-case products I 37. Worst-case products II 38. Toxicity study 39. Considerations I 40. Considerations II 41. Maximum Daily Dose 42. Surface residue limits 43. Calculating SAL 44. Summary 45. Review WRITING PROTOCOLS 46. Introduction 47. Worst-case conditions 48. Sampling locations 49. Applying the protocol 50. Are we prepared? 51. Documenting results 52. Summary 53. Review REPORT DOCUMENT 54. Introduction 55. On-going requirements 56. Review CONCLUSION 57. Summary |
COURSE OBJECTIVES
Students completing this course should be able to:
|
SeerPharma has partnered with GeneEd to now distribute courses in Major Therapeutic Areas, Clinical Research, and Biotechnology & Genetics.
© SeerPharma Pty Ltd 2008 | Resources | Privacy Policy