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Table of Contents
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