Contents: 1. Why Validation? 2. Facility Design for Validation 3. Modular Facilities – Meeting the Need for
Flexibility 4. Commissioning and Qualification 5. Design & Qualification of Controlled
Environments 6. Validation of Pharmaceutical Water Systems 7. Validation of Critical Utilities 8. Calibration and Metrology 9. Risk Management and Thermal Validation 10. Change Control 11. Microbiology of Sterilization Processes 12. Biological Indicators 13. Steam Sterilization in Autoclaves 14. Validation of Terminal Sterilization 15. Steam Sterilization-in-Place Technology and
Validation 16. Dry Heat Sterilization 17. Depyrogenation by Inactivation and Removal 18. Ethylene Oxide Sterilization 19. Validation of chlorine dioxide Sterilization 20. Liquid Phase Sterilization 21. Vapor Sterilization and Decontamination 22. Validation of the Radiation Sterilization of
Pharmaceuticals 23. Validation of Sterilizing Grade Filters 24. Disinfecting Agents: The Art of Disinfection 25. Cleaning and Disinfecting Laminar Flow
Workstations, Bio Safety Cabinets and Fume Hoods 26. Contamination Control for Component
Introduction to Classified Areas 27. Aseptic Processing for Dosage Form Manufacture 28. Validation of Manual Aseptic Processes 29. Validation of Aseptic Processing for Bulk
Pharmaceutical Chemicals 30. Qualification and Validation of Advanced
Aseptic Processing Technologies 31. Total Particle Monitoring 32. Environmental Monitoring 33. Validation of Container Component Preparation 34. Validation of Lyophilization 35. Validation of Packaging Processes for Sterile
Products 36. Validation of Active Pharmaceutical
Ingredients 37. Cell Culture Process Validation including
Cell Bank Qualification 38. Validation of Recovery and Purification
Processes 39. Validation of Process Chromatography 40. Single Use Technologies and Systems 41. Considerations for Process Validation for
Cell and Gene Therapies 42. Validation of Solid Dosage Forms 43. Validation of Validation of Oral / Topical
Liquids & Semi-Solids 44. Validation of Non-Sterile Packaging Operations 45. Validation of Cleaning Processes 46. Validation of Training 47. Vendor Qualification and Validation 48. Validation of Clinical Trial Manufacturing 49. Validation of New Products 50. Retrospective / Continuous Process
Validation 51. Validation & 6 Sigma 52. Validation and Contract
Manufacturing 53. Computerized Systems Validation 54. Risk Based Validation of Laboratory
Information Management Systems 55. Control Systems Validation 56. Process Analytical Technology and Validation 57. Validation of Analytical Procedures and
Physical Methods 58. Validation of Microbial Methods 59. "Rapid Methods for Aseptic Processing
and Their Validation" 60. Extractables and Leachables in Drug Products:
An Overview 61. Evolution and Implementation of Validation in
the United States 62. Validation in Europe - What are the
Differences? 63. Japanese Approach to Validation 64. Organization of Validation in a Multi National
Pharmaceutical Company 65. Validation in a Small Pharmaceutical Company 66. Regulatory Aspects of Process Validation in
the United States 67. The Future of Validation |
