TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR

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Technology Transfer of Sterile Products Technology Transfer Governing Factors Time Cost Science Compliance 18
Technology Transfer Process/Phases 1. Quality Agreement/ Project Scope Document 2. Technology Transfer Document 3. Project Execution/Implementation 19
Page 1 and 2: TECHNOLOGY TRANSFER OF STERILE PROP
Page 3 and 4: Overview Current Status of Pharmac
Page 5 and 6: Status of Pharmaceuticals and Bioph
Page 7 and 8: Late-Stage Biotech Development (Sou
Page 9 and 10: Types of Technology Transfer Origin
Page 11 and 12: Phase IV Typical Drug Development P
Page 13 and 14: Needs for Technology Transfer Reaso
Page 15 and 16: Phases In Evolution of Production S
Page 17: Schematic to Summarize Technology T
Page 21 and 22: Technology Transfer Process 2. Tech
Page 23 and 24: Technology Transfer Process 2. Tech
Page 25 and 26: Technology Transfer Process 3. Vali
Page 27 and 28: Technology Transfer Process 3. Vali
Page 29 and 30: Technology Transfer Phases 3. Proje
Page 31 and 32: Schematic of Representative Bulk Pr
Page 33 and 34: Schematic of Representative Fill Fi
Page 35 and 36: Aseptic Manufacturing - Isolators V
Page 37 and 38: How to Conduct Technology Transfer
Page 39 and 40: Hypothetical Technology Transfer S
Page 41 and 42: Technology Transfer for Lyo Product
Page 63 and 64: Hypothetical Technology Transfer (S
Page 69 and 70:
Hypothetical Technology Transfer (S
Page 71 and 72:
Using CMO for Technology Transfer
Page 73 and 74:
Technology Transfer Essentials Pro
Page 75 and 76:
Technology Transfer Essentials Pro
Page 77 and 78:
Technology Transfer Success Factors
Page 79 and 80:
A Case Study Mixing Validation 79
Page 81 and 82:
Case Study - Mixing Validation •
Page 83 and 84:
Page 85 and 86:
Page 87 and 88:
Thank you Questions 87
Page 89 and 90:
Strategy for Characterization of Ra
Page 91 and 92:
Air Classification Clean-Area Class
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TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR

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