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A History of a cGMP Medical Event Investigation



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This is the 1st edition with a publication date of 1/29/2013.

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This book explains the application of the FDA Investigational and New Drug application process, FDA Current Good Manufacturing Practice regulations (cGMP) and Design for Six Sigma (DMADV) in the identification of Customer Requirements, Measurement and Analysis, Design Specifications, and Process Verification and Product Validation.  The Six Sigma methodologies are discussed with examples in preparation of a Project Charter with a supplied format; how to manage and document a team meeting; examples of the application of Failure Mode Effect Analysis (FMEA), Quality Functional Deployment (QFD), and the Design Fish-Bone Diagram applied in the design of a coffee cup; an explanation of capability indexes (Cp, Ppk, Cpk) including an example of a Design Of Experiments (DOE) based on improving the capability of a molding operation; and a DMAIC Investigation specific to identifying the cause of failure implicated in the case.

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

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