TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR

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Technology Transfer Essentials Working Relationship and Communication ‣ Very critical for success of Technology Transfer ‣ Should be viewed as win-win partnership and teamwork ‣ Routine team meetings via phone and periodic face-to to-face meetings very crucial. ‣ Nothing can replace the value of periodic face-to to- face meeting so its cost be factored in budget. 76
Technology Transfer Success Factors Well developed, robust process with all identified weakness Well defined documented project management covering all areas of project Excellent project management teams Proper project execution and tracking system and suitable team membership Senior management oversight and involvement Open and structured communication Collaborative working relationship between client and customer Fully aligned expectations of both parties 77
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TECHNOLOGY TRANSFER OF STERILE PROP
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Overview Current Status of Pharmac
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Status of Pharmaceuticals and Bioph
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Late-Stage Biotech Development (Sou
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Types of Technology Transfer Origin
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Phase IV Typical Drug Development P
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Needs for Technology Transfer Reaso
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Phases In Evolution of Production S
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Schematic to Summarize Technology T
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Technology Transfer Process/Phases
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Technology Transfer Process 2. Tech
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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 71 and 72: Using CMO for Technology Transfer
Page 73 and 74: Technology Transfer Essentials Pro
Page 75: Technology Transfer Essentials Pro
Page 79 and 80: A Case Study Mixing Validation 79
Page 81 and 82: Case Study - Mixing Validation •
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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