Buch, Englisch, 252 Seiten, Format (B × H): 152 mm x 234 mm, Gewicht: 318 g
Buch, Englisch, 252 Seiten, Format (B × H): 152 mm x 234 mm, Gewicht: 318 g
ISBN: 978-1-118-39661-2
Verlag: Turner Publishing Company
Autoren/Hrsg.
Fachgebiete
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizintechnik, Biomedizintechnik, Medizinische Werkstoffe
- Technische Wissenschaften Sonstige Technologien | Angewandte Technik Medizintechnik, Biomedizintechnik
- Wirtschaftswissenschaften Betriebswirtschaft Management Qualitätsmanagement, Qualitätssicherung (QS), Total Quality Management (TQM)
- Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
- Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Chemische Verfahrenstechnik
- Technische Wissenschaften Maschinenbau | Werkstoffkunde Produktionstechnik Industrielle Qualitätskontrolle
Weitere Infos & Material
Preface xi
Part One The Event 1
1 Francesca 3
Part Two Drug Discovery: Five Years Earlier 9
2 Katlin Bioscience: Transgenic Mouse Study 11
3 Oxy-Fox Inhaler 21
3.1 Kinnen Laboratories 21
3.2 Kinnen Laboratories: Oxy-Fox Transfer 22
3.3 Due-Diligence Team and Katlin Data Acceptance 23
Part Three Kinnen Oxy-Fox Inhaler Market Launch Program 25
4 Agency IND and NDA Requirements, Six Sigma Charter, and Device Master Record 27
4.1 Launch Team Meeting Number 1 27
4.2 Meeting with Medical Affairs: Toxicity Studies 46
5 Meeting Minutes Guidelines 49
5.1 Launch Team Meeting Number 2 49
6 Project Timing, Marketing Plan, and Offshore Molding 55
6.1 Launch Team Meeting Number 3 55
6.2 Project Financial Review 61
6.3 Progress Meeting: Who Takes Credit for What? 64
6.4 Morning Meeting: Just-in-Time Manufacturing 65
7 cGMP Process Validation Requirements 69
7.1 Launch Team Meeting Number 4 69
8 Failure Mode Effects Analysis 81
8.1 Launch Team Meeting Number 5 81
9 Design for Manufacturability, Design for Six Sigma, Concurrent Design 93
9.1 Product Development Meeting Number 1 93
9.2 Update Meeting with Ed Chase and Gordon Taylor 102
10 Design Fishbone Diagram 105
10.1 Launch Team Meeting Number 6 105
11 Product Specifications 111
11.1 Product Development Meeting Number 2 111
12 Design Control 115
12.1 Design Team Meeting Number 7 115
12.2 Product Development Staff Meeting 118
12.3 Engineering One-on-One 119
12.4 Program Update 120
13 Design of Experiments (DOE) 123
13.1 Molding Team Meeting 123
14 Start-Up Issues 129
14.1 Oxy-Fox Inhaler Wrap-Up and Equipment Start-Up 129
14.2 The Final Management Review 135
Part Four Present Day: Funeral 139
15 Grief 141
16 The Autopsy Results 145
17 The Agency 151
Part Five Agency Medical Event Letter 155
18 Kinnen Notification 157
18.1 Another Agency Letter 157
18.2 Medical Event Review Meeting 158
19 Investigation Team Management 161
19.1. Morning Meeting with Gail Strom, Marcia Hines, and Dan Garvey 161
20 DMAIC Investigation Process 163
21 Internal Quality Review 171
21.1 Meeting with Gail Strom and Marcia Hines 171
21.2 Executive Management Review 174
22 The Agency Audit Letter 179
23 Agency Arrival 183
24 The Audit 187
24.1 Agency Meeting to Review Qualification Documents and the Quality Acceptance Records of First Lot to Stock 187
24.2 Agency Meeting to Review the Oxy-Fox Inhaler Lot Used in the NDA Clinical Studies 189
24.3 Agency Meeting to Review the Design and Program Team Meeting Minutes 190
24.4 Agency Meeting to Review the Due-Diligence Report Katlin Studies, and Oxy-Fox Design History File, 192
25 End-of-Day Agency Wrap-Up Meeting 197
26 Kinnen Management Review 201
Part Six Reckoning 207
27 Blame and Responsibility 209
27.1 The Investigation Is a Public Record 209
27.2 Kinnen Wrap-Up 210
28 Closure 213
Bibliography 215
Index 217