| COURSE OUTLINE
VALIDATION MASTER PLAN 1. Outcomes 2. First Class Pharmaceuticals 3. Introduction 4. Definitions and standar 5. The new line 6. Glossary of terms 7. VMP Structure 8. Importance of VMP 9. VMP and responsibilities 10. Regulatory requirements 11. VMP sections 12. VMP content 13. Summary 14. Review SCOPE OF THE VMP 15. Introduction 16. Using risk assessment 17. Defining risk 18. Critical vs non-critical 19. Risk assessment approach 20. Validation strategy 21. Validation policies 22. Qualification phases 23. Equipment qualification 24. Developing a plan 25. Summary 26. Review VALIDATION DOCUMENTATION 27. Introduction 28. Documentation overview 29. Interrelations 30. Reference documents 31. Authorising validation 32. Organising validation 33. Using protocol templates 34. Change control 35. Required procedures 36. Handling deviations 37. Validation data 38. Tracking and cataloguing 39. Archiving and retrieving 40. Report and certification 41. Summary 42. Review CHANGE CONTROL 43. Introduction 44. Change management 45. Reporting rules 46. Summary 47. Review |
COURSE OBJECTIVES
Students completing this course should be able to:
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