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Good quality practice (GQP) in pharmaceutical manufacturing : a handbook / / authored by Jordi Botet, Glez. Tablas 17, Barcelona Spain
| Good quality practice (GQP) in pharmaceutical manufacturing : a handbook / / authored by Jordi Botet, Glez. Tablas 17, Barcelona Spain |
| Autore | Botet Jordi |
| Pubbl/distr/stampa | Sharjah : , : Bentham Science Publishers, Limited, , [2015] |
| Descrizione fisica | 1 online resource (504 p.) |
| Soggetto topico |
Pharmaceutical industry
Pharmaceutical industry - Management |
| ISBN | 1-68108-114-8 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Cover; Title; EUL; Dedication; Contents; Foreword; Preface; Chapter 01; Chapter 02; Chapter 03; Chapter 04; Chapter 05; Chapter 06; Chapter 07; Chapter 08; Chapter 09; Chapter 10; Chapter 11; Chapter 12; Bibliography; Index; Back Cover |
| Record Nr. | UNINA-9910818587703321 |
Botet Jordi
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| Sharjah : , : Bentham Science Publishers, Limited, , [2015] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Pharmaceutical computer systems validation : quality assurance, risk management and regulatory compliance / / edited by Guy Wingate
| Pharmaceutical computer systems validation : quality assurance, risk management and regulatory compliance / / edited by Guy Wingate |
| Edizione | [2nd ed.] |
| Pubbl/distr/stampa | New York : , : Informa Healthcare, , 2010 |
| Descrizione fisica | 1 online resource (773 p.) |
| Disciplina |
615.1068/4
615.10684 |
| Altri autori (Persone) | WingateGuy |
| Soggetto topico |
Pharmaceutical industry - Management
Pharmaceutical industry - Data processing Health facilities - Risk management Risk management - Data processing |
| Soggetto genere / forma | Electronic books. |
| ISBN |
0-429-13762-1
1-282-56102-2 9786612561023 1-4200-8895-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Foreword to the Second Edition; Foreword to the First Edition; Preface; Contributor Biographies; Abbreviations; Contents; Chapter 1. Introduction; Chapter 2. Organization and Management; Chapter 3. Supporting Processes; Chapter 4. Prospective Verification and Validation; Chapter 5. Project Initiation and Compliance Determination; Chapter 6. Requirements Capture and Supplier (Vendor)Selection; Chapter 7. Design and Development; Chapter 8. Coding, Configuration, and Build; Chapter 9. Development Testing; Chapter 10. User Qualification and Authorization to Use
Chapter 11. Operation and MaintenanceChapter 12. Phaseout and Withdrawal; Chapter 13. Electronic Records and Electronic Signatures; Chapter 14. Regulatory Inspections; Chapter 15. Compliance Strategies; Chapter 16. Capabilities, Measures, and Performance; Chapter 17. Practical Troubleshooting; Chapter 18. Concluding Remarks; Chapter 19. Case Study 1: Computerized Analytical Laboratory Systems; Chapter 20. Case Study 2: Chromatography Data Systems; Chapter 21. Case Study 3: Laboratory Information Management Systems; Chapter 22. Case Study 4: Clinical Systems Chapter 23. Case Study 5: Control and Monitoring InstrumentationChapter 24. Case Study 6: Process Control Systems; Chapter 25. Case Study 7: Manufacturing Execution Systems and Electronic Batch Records; Chapter 26. Case Study 8: Building Management Systems; Chapter 27. Case Study 9: Engineering Management Systems; Chapter 28. Case Study 10: Desktop Applications Including Spreadsheets; Chapter 29. Case Study 11: Databases; Chapter 30. Case Study 12: Electronic Document Management Systems; Chapter 31. Case Study 13: Enterprise Resource Planning Systems Chapter 32. Case Study 14: Marketing and Supply ApplicationsChapter 33. Case Study 15: IT Infrastructure and Associated Services; Chapter 34. Case Study 16: Internet/Intranet Applications; Chapter 35. Case Study 17: Medical Devices and Their Automated Manufacture; Chapter 36. Case Study 18: Blood Establishment Computer Systems; Chapter 37. Case Study 19: Process Analytical Technology; Chapter 38. Case Study 20: Computer Applications Supporting the Supply of Biotechnology Products; Glossary; Back Cover |
| Record Nr. | UNINA-9910459271703321 |
| New York : , : Informa Healthcare, , 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmaceutical computer systems validation : quality assurance, risk management and regulatory compliance / / edited by Guy Wingate
| Pharmaceutical computer systems validation : quality assurance, risk management and regulatory compliance / / edited by Guy Wingate |
| Edizione | [2nd ed.] |
| Pubbl/distr/stampa | New York : , : Informa Healthcare, , 2010 |
| Descrizione fisica | 1 online resource (773 p.) |
| Disciplina |
615.1068/4
615.10684 |
| Altri autori (Persone) | WingateGuy |
| Soggetto topico |
Pharmaceutical industry - Management
Pharmaceutical industry - Data processing Health facilities - Risk management Risk management - Data processing |
| ISBN |
0-429-13762-1
1-282-56102-2 9786612561023 1-4200-8895-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Foreword to the Second Edition; Foreword to the First Edition; Preface; Contributor Biographies; Abbreviations; Contents; Chapter 1. Introduction; Chapter 2. Organization and Management; Chapter 3. Supporting Processes; Chapter 4. Prospective Verification and Validation; Chapter 5. Project Initiation and Compliance Determination; Chapter 6. Requirements Capture and Supplier (Vendor)Selection; Chapter 7. Design and Development; Chapter 8. Coding, Configuration, and Build; Chapter 9. Development Testing; Chapter 10. User Qualification and Authorization to Use
Chapter 11. Operation and MaintenanceChapter 12. Phaseout and Withdrawal; Chapter 13. Electronic Records and Electronic Signatures; Chapter 14. Regulatory Inspections; Chapter 15. Compliance Strategies; Chapter 16. Capabilities, Measures, and Performance; Chapter 17. Practical Troubleshooting; Chapter 18. Concluding Remarks; Chapter 19. Case Study 1: Computerized Analytical Laboratory Systems; Chapter 20. Case Study 2: Chromatography Data Systems; Chapter 21. Case Study 3: Laboratory Information Management Systems; Chapter 22. Case Study 4: Clinical Systems Chapter 23. Case Study 5: Control and Monitoring InstrumentationChapter 24. Case Study 6: Process Control Systems; Chapter 25. Case Study 7: Manufacturing Execution Systems and Electronic Batch Records; Chapter 26. Case Study 8: Building Management Systems; Chapter 27. Case Study 9: Engineering Management Systems; Chapter 28. Case Study 10: Desktop Applications Including Spreadsheets; Chapter 29. Case Study 11: Databases; Chapter 30. Case Study 12: Electronic Document Management Systems; Chapter 31. Case Study 13: Enterprise Resource Planning Systems Chapter 32. Case Study 14: Marketing and Supply ApplicationsChapter 33. Case Study 15: IT Infrastructure and Associated Services; Chapter 34. Case Study 16: Internet/Intranet Applications; Chapter 35. Case Study 17: Medical Devices and Their Automated Manufacture; Chapter 36. Case Study 18: Blood Establishment Computer Systems; Chapter 37. Case Study 19: Process Analytical Technology; Chapter 38. Case Study 20: Computer Applications Supporting the Supply of Biotechnology Products; Glossary; Back Cover |
| Record Nr. | UNINA-9910792350003321 |
| New York : , : Informa Healthcare, , 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmaceutical computer systems validation : quality assurance, risk management and regulatory compliance / / edited by Guy Wingate
| Pharmaceutical computer systems validation : quality assurance, risk management and regulatory compliance / / edited by Guy Wingate |
| Edizione | [2nd ed.] |
| Pubbl/distr/stampa | New York : , : Informa Healthcare, , 2010 |
| Descrizione fisica | 1 online resource (773 p.) |
| Disciplina |
615.1068/4
615.10684 |
| Altri autori (Persone) | WingateGuy |
| Soggetto topico |
Pharmaceutical industry - Management
Pharmaceutical industry - Data processing Health facilities - Risk management Risk management - Data processing |
| ISBN |
0-429-13762-1
1-282-56102-2 9786612561023 1-4200-8895-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Foreword to the Second Edition; Foreword to the First Edition; Preface; Contributor Biographies; Abbreviations; Contents; Chapter 1. Introduction; Chapter 2. Organization and Management; Chapter 3. Supporting Processes; Chapter 4. Prospective Verification and Validation; Chapter 5. Project Initiation and Compliance Determination; Chapter 6. Requirements Capture and Supplier (Vendor)Selection; Chapter 7. Design and Development; Chapter 8. Coding, Configuration, and Build; Chapter 9. Development Testing; Chapter 10. User Qualification and Authorization to Use
Chapter 11. Operation and MaintenanceChapter 12. Phaseout and Withdrawal; Chapter 13. Electronic Records and Electronic Signatures; Chapter 14. Regulatory Inspections; Chapter 15. Compliance Strategies; Chapter 16. Capabilities, Measures, and Performance; Chapter 17. Practical Troubleshooting; Chapter 18. Concluding Remarks; Chapter 19. Case Study 1: Computerized Analytical Laboratory Systems; Chapter 20. Case Study 2: Chromatography Data Systems; Chapter 21. Case Study 3: Laboratory Information Management Systems; Chapter 22. Case Study 4: Clinical Systems Chapter 23. Case Study 5: Control and Monitoring InstrumentationChapter 24. Case Study 6: Process Control Systems; Chapter 25. Case Study 7: Manufacturing Execution Systems and Electronic Batch Records; Chapter 26. Case Study 8: Building Management Systems; Chapter 27. Case Study 9: Engineering Management Systems; Chapter 28. Case Study 10: Desktop Applications Including Spreadsheets; Chapter 29. Case Study 11: Databases; Chapter 30. Case Study 12: Electronic Document Management Systems; Chapter 31. Case Study 13: Enterprise Resource Planning Systems Chapter 32. Case Study 14: Marketing and Supply ApplicationsChapter 33. Case Study 15: IT Infrastructure and Associated Services; Chapter 34. Case Study 16: Internet/Intranet Applications; Chapter 35. Case Study 17: Medical Devices and Their Automated Manufacture; Chapter 36. Case Study 18: Blood Establishment Computer Systems; Chapter 37. Case Study 19: Process Analytical Technology; Chapter 38. Case Study 20: Computer Applications Supporting the Supply of Biotechnology Products; Glossary; Back Cover |
| Record Nr. | UNINA-9910800061903321 |
| New York : , : Informa Healthcare, , 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmaceutical computer systems validation : quality assurance, risk management and regulatory compliance / / edited by Guy Wingate
| Pharmaceutical computer systems validation : quality assurance, risk management and regulatory compliance / / edited by Guy Wingate |
| Edizione | [2nd ed.] |
| Pubbl/distr/stampa | New York : , : Informa Healthcare, , 2010 |
| Descrizione fisica | 1 online resource (773 p.) |
| Disciplina |
615.1068/4
615.10684 |
| Altri autori (Persone) | WingateGuy |
| Soggetto topico |
Pharmaceutical industry - Management
Pharmaceutical industry - Data processing Health facilities - Risk management Risk management - Data processing |
| ISBN |
0-429-13762-1
1-282-56102-2 9786612561023 1-4200-8895-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Foreword to the Second Edition; Foreword to the First Edition; Preface; Contributor Biographies; Abbreviations; Contents; Chapter 1. Introduction; Chapter 2. Organization and Management; Chapter 3. Supporting Processes; Chapter 4. Prospective Verification and Validation; Chapter 5. Project Initiation and Compliance Determination; Chapter 6. Requirements Capture and Supplier (Vendor)Selection; Chapter 7. Design and Development; Chapter 8. Coding, Configuration, and Build; Chapter 9. Development Testing; Chapter 10. User Qualification and Authorization to Use
Chapter 11. Operation and MaintenanceChapter 12. Phaseout and Withdrawal; Chapter 13. Electronic Records and Electronic Signatures; Chapter 14. Regulatory Inspections; Chapter 15. Compliance Strategies; Chapter 16. Capabilities, Measures, and Performance; Chapter 17. Practical Troubleshooting; Chapter 18. Concluding Remarks; Chapter 19. Case Study 1: Computerized Analytical Laboratory Systems; Chapter 20. Case Study 2: Chromatography Data Systems; Chapter 21. Case Study 3: Laboratory Information Management Systems; Chapter 22. Case Study 4: Clinical Systems Chapter 23. Case Study 5: Control and Monitoring InstrumentationChapter 24. Case Study 6: Process Control Systems; Chapter 25. Case Study 7: Manufacturing Execution Systems and Electronic Batch Records; Chapter 26. Case Study 8: Building Management Systems; Chapter 27. Case Study 9: Engineering Management Systems; Chapter 28. Case Study 10: Desktop Applications Including Spreadsheets; Chapter 29. Case Study 11: Databases; Chapter 30. Case Study 12: Electronic Document Management Systems; Chapter 31. Case Study 13: Enterprise Resource Planning Systems Chapter 32. Case Study 14: Marketing and Supply ApplicationsChapter 33. Case Study 15: IT Infrastructure and Associated Services; Chapter 34. Case Study 16: Internet/Intranet Applications; Chapter 35. Case Study 17: Medical Devices and Their Automated Manufacture; Chapter 36. Case Study 18: Blood Establishment Computer Systems; Chapter 37. Case Study 19: Process Analytical Technology; Chapter 38. Case Study 20: Computer Applications Supporting the Supply of Biotechnology Products; Glossary; Back Cover |
| Record Nr. | UNINA-9910829396503321 |
| New York : , : Informa Healthcare, , 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Portfolio, program, and project management in the pharmaceutical and biotechnology industries [[electronic resource] /] / edited by Pete Harpum
| Portfolio, program, and project management in the pharmaceutical and biotechnology industries [[electronic resource] /] / edited by Pete Harpum |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2010 |
| Descrizione fisica | 1 online resource (352 p.) |
| Disciplina | 615.1068/4 |
| Altri autori (Persone) | HarpumPete |
| Soggetto topico |
Pharmaceutical industry - Management
Biotechnology industries - Management Project management |
| ISBN |
0-470-88896-2
1-282-55051-9 9786612550515 0-470-60378-X 0-470-60377-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries; Contents; Preface; Acknowledgments; About the Authors; Part One The Life Science Industry Context for Portfolio, Program, and Project Management; 1. A Review of Project Management in Life Science Industry Sectors; 2. The Impact of Organizational Size on Drug Project Management; 3. Drug Development in Biotechnology and How We Can Do It Better; Part Two The Portfolio, Program, and Project Management Approaches and Processes
4. An Overview of the Organization and Processes of Portfolio, Program, and Project Management5. Portfolio Management in the Pharmaceutical Industry: Balancing Corporate Need with the Reality of Delivering Products to the Market; 6. Program Management in Drug Development; 7. Project Control; 8. Managing Uncertainty in Drug Projects; 9. Managing Drug Safety Risk; 10. Developing Program Strategy; 11. Developing Products with "Added Value"; Part Three Integrating the Processes; 12. Integrated Business Processes to Support Cross-Functional Drug Development 13. Integrated Drug Development: From Cradle to Grave and from Lab to Market14. The Development of P(3)M Capability in Drug Development Organizations; 15. Implementing Portfolio, Program, and Project Management Best Practices in Drug Development Organizations; Bibliography; Index |
| Record Nr. | UNINA-9910140602803321 |
| Hoboken, N.J., : John Wiley & Sons, c2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Portfolio, program, and project management in the pharmaceutical and biotechnology industries [[electronic resource] /] / edited by Pete Harpum
| Portfolio, program, and project management in the pharmaceutical and biotechnology industries [[electronic resource] /] / edited by Pete Harpum |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2010 |
| Descrizione fisica | 1 online resource (352 p.) |
| Disciplina | 615.1068/4 |
| Altri autori (Persone) | HarpumPete |
| Soggetto topico |
Pharmaceutical industry - Management
Biotechnology industries - Management Project management |
| ISBN |
0-470-88896-2
1-282-55051-9 9786612550515 0-470-60378-X 0-470-60377-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries; Contents; Preface; Acknowledgments; About the Authors; Part One The Life Science Industry Context for Portfolio, Program, and Project Management; 1. A Review of Project Management in Life Science Industry Sectors; 2. The Impact of Organizational Size on Drug Project Management; 3. Drug Development in Biotechnology and How We Can Do It Better; Part Two The Portfolio, Program, and Project Management Approaches and Processes
4. An Overview of the Organization and Processes of Portfolio, Program, and Project Management5. Portfolio Management in the Pharmaceutical Industry: Balancing Corporate Need with the Reality of Delivering Products to the Market; 6. Program Management in Drug Development; 7. Project Control; 8. Managing Uncertainty in Drug Projects; 9. Managing Drug Safety Risk; 10. Developing Program Strategy; 11. Developing Products with "Added Value"; Part Three Integrating the Processes; 12. Integrated Business Processes to Support Cross-Functional Drug Development 13. Integrated Drug Development: From Cradle to Grave and from Lab to Market14. The Development of P(3)M Capability in Drug Development Organizations; 15. Implementing Portfolio, Program, and Project Management Best Practices in Drug Development Organizations; Bibliography; Index |
| Record Nr. | UNINA-9910813866703321 |
| Hoboken, N.J., : John Wiley & Sons, c2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Process systems engineering for pharmaceutical manufacturing / / edited by Ravendra Singh and Zhihong Yuan
| Process systems engineering for pharmaceutical manufacturing / / edited by Ravendra Singh and Zhihong Yuan |
| Pubbl/distr/stampa | Amsterdam, Netherlands : , : Elsevier, , 2018 |
| Descrizione fisica | 1 online resource (675 pages) |
| Disciplina | 620.001171 |
| Collana | Computer-Aided Chemical Engineering |
| Soggetto topico |
Systems engineering
Pharmaceutical industry - Management Manufacturing processes |
| ISBN |
0-444-63966-7
0-444-63963-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910736998503321 |
| Amsterdam, Netherlands : , : Elsevier, , 2018 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Project management for the pharmaceutical industry / / Laura Brown and Tony Grundy
| Project management for the pharmaceutical industry / / Laura Brown and Tony Grundy |
| Autore | Brown Laura (Laura Sophia Rose) |
| Edizione | [Revised edition.] |
| Pubbl/distr/stampa | London : , : Routledge, , 2016 |
| Descrizione fisica | 1 online resource (299 p.) |
| Disciplina | 615/.1/0684 |
| Altri autori (Persone) | GrundyTony <1954-> |
| Soggetto topico |
Pharmaceutical industry - Management
Project management |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-317-07513-7
1-317-07512-9 1-315-60240-7 1-283-11551-4 9786613115515 1-4094-1895-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Cover; Contents; List of Figures; List of Tables; Preface; 1 Managing Pharmaceutical Projects Strategically; 2 Linking Pharmaceutical Projects with Business Strategy; 3 Defining Pharmaceutical Projects; 4 Developing Pharmaceutical Project Strategy and Plans; 5 Evaluating Pharmaceutical Projects; 6 Pharmaceutical Project Mobilisation, Control and Learning; 7 Influencing People and Behaviour; 8 Project Management Checklists and Cost-management Project Case Study; 9 Conclusion; Glossary of Key Project Management Definitions; Bibliography; Index |
| Record Nr. | UNINA-9910456877903321 |
|
Brown Laura (Laura Sophia Rose)
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| London : , : Routledge, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Project management for the pharmaceutical industry / / Laura Brown and Tony Grundy
| Project management for the pharmaceutical industry / / Laura Brown and Tony Grundy |
| Autore | Brown Laura (Laura Sophia Rose) |
| Edizione | [Revised edition.] |
| Pubbl/distr/stampa | London : , : Routledge, , 2016 |
| Descrizione fisica | 1 online resource (299 p.) |
| Disciplina | 615/.1/0684 |
| Altri autori (Persone) | GrundyTony <1954-> |
| Soggetto topico |
Pharmaceutical industry - Management
Project management |
| ISBN |
1-4094-5908-X
1-317-07513-7 1-317-07512-9 1-315-60240-7 1-283-11551-4 9786613115515 1-4094-1895-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Cover; Contents; List of Figures; List of Tables; Preface; 1 Managing Pharmaceutical Projects Strategically; 2 Linking Pharmaceutical Projects with Business Strategy; 3 Defining Pharmaceutical Projects; 4 Developing Pharmaceutical Project Strategy and Plans; 5 Evaluating Pharmaceutical Projects; 6 Pharmaceutical Project Mobilisation, Control and Learning; 7 Influencing People and Behaviour; 8 Project Management Checklists and Cost-management Project Case Study; 9 Conclusion; Glossary of Key Project Management Definitions; Bibliography; Index |
| Record Nr. | UNINA-9910781375403321 |
|
Brown Laura (Laura Sophia Rose)
|
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| London : , : Routledge, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
