Part One The Event.
Chapter 1 Francesca
Part Two Drug Discovery five years earlier
Chapter 2 Katlin BioScience - Transgenic Mouse Study
Chapter 3 Oxy-Fox Inhaler
3.1 Kinnen Laboratories.
3.2 Kinnen Laboratories ? Oxy-Fox transfer.
3.3 Due diligence Team - Katlin data Acceptance.
Part Three Kinnen Oxy-Fox Inhaler Market Launch Program
Chapter 4 - Agency IND and NDA Requirements - Six-Sigma Charter - Device Master Record
4.1 Launch Team Meeting number 1
4.2 Meeting with Medical Affairs ? Toxicity Studies
Chapter 5 Meeting Minutes Guidelines.
5.1 Launch Team Meeting number 2
Chapter 6 Project Timing ? Marketing Plan ? Offshore Molding
6.1 Launch Team Meeting Number 3
6.2 Project Financial Review.
6.3 Progress meeting. - Who takes credit for what?
6.4 Morning meeting - Just in Time Manufacturing
Chapter 7 - Process Validation Requirements
7.1 Launch Team Meeting number 4
Chapter 8 - - Failure Mode Effects Analysis
8.1 Launch Team Meeting number 5
Chapter 9 - Design for Manufacturability ? Design for Six Sigma ? Concurrent design.
9.1 Product Development meeting number 1
9.2 Update meeting with Ed Chase and Gordon Taylor
Chapter 10 - Design Fish-Bone Diagram
10.1 Launch Team Meeting number 6
Chapter 11 - Product Specifications
11.1 Product Development meeting number 2
Chapter 12 Design Control.
12.1 Design Team Meeting number 6
12.2 Product Development Staff Meeting
12.3 Engineering one-on-one.
12.4 Program update.
Chapter 13 - Design of Experiments - DOE
13.1 Molding Team Meeting
Chapter 14 Start-up Issues
14.1 Oxy-Fox Inhaler Wrap up and Equipment Start-up
Part four Present day - Funeral
Chapter 15 - Grief
Chapter 16 - The autopsy results
Chapter 17 - The Agency
Part Five - Agency Medical Event letter
Chapter 18 - Kinnen Notification
18.1 Another Agency letter
18.2 Medical Event Review Meeting
Chapter 19 - Investigation Team Management
Chapter 20 - DMAIC Investigation Process - MAIC
Chapter 21 Internal Quality Review
21.1 Meeting with Gail Strom and Marcia Hines
21.2 Executive Management Review
Chapter 22 - The Agency Audit Letter
Chapter 23 - Agency Arrival
Chapter 24 - The Audit
24.1 Agency meeting to review the Qualification documents and first lot to stock quality acceptance records
24.2 Agency meeting to review the Oxy-Fox Inhaler lot used in the NDA Clinical Studies.
24.3 Agency meeting to review the Design and Program team meeting minutes.
24.4 Agency meeting to review the Due-Diligence report, Katlin studies, and Oxy-Fox Design History File.
Chapter 25 - End of day Agency wrap up meeting
Chapter 26 - Kinnen Management Review
Part Six - Reckoning
Chapter 27 - Blame and Responsibility
27.1 The Investigation is a public record.
Chapter 29 Closure
The New copy of this book will include any supplemental materials advertised. Please check the title of the book to determine if it should include any access cards, study guides, lab manuals, CDs, etc.
The Used, Rental and eBook copies of this book are not guaranteed to include any supplemental materials. Typically, only the book itself is included. This is true even if the title states it includes any access cards, study guides, lab manuals, CDs, etc.