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Produktbild: A History of a Cgmp Medical Event Investigation

A History of a Cgmp Medical Event Investigation

Fr. 69.90

inkl. gesetzl. MwSt., Versandkostenfrei

Beschreibung

Produktdetails

Einband

Taschenbuch

Erscheinungsdatum

10.12.2012

Verlag

John Wiley & Sons

Seitenzahl

252

Maße (L/B/H)

23.4/15.2/2 cm

Gewicht

318 g

Auflage

1. Auflage

Sprache

Englisch

ISBN

978-1-118-39661-2

Beschreibung

Produktdetails

Einband

Taschenbuch

Erscheinungsdatum

10.12.2012

Verlag

John Wiley & Sons

Seitenzahl

252

Maße (L/B/H)

23.4/15.2/2 cm

Gewicht

318 g

Auflage

1. Auflage

Sprache

Englisch

ISBN

978-1-118-39661-2

Herstelleradresse

Libri GmbH
Europaallee 1
36244 Bad Hersfeld
DE

Email: gpsr@libri.de

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  • Produktbild: A History of a Cgmp Medical Event Investigation
  • 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