A history of a cGMP medical event investigation / (Record no. 19995)

MARC details
000 -LEADER
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001 - CONTROL NUMBER
control field ocn823645667
003 - CONTROL NUMBER IDENTIFIER
control field OCoLC
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20230823095612.0
006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS--GENERAL INFORMATION
fixed length control field m o d
007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION
fixed length control field cr cnu---unuuu
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 130108s2013 nju ob 001 0 eng d
040 ## - CATALOGING SOURCE
Original cataloging agency N$T
Language of cataloging eng
Description conventions pn
Transcribing agency N$T
Modifying agency YDXCP
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019 ## -
-- 823726452
-- 864914126
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 9781118494943
Qualifying information (electronic bk.)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 1118494946
Qualifying information (electronic bk.)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 9781118494936
Qualifying information (electronic bk.)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 1118494938
Qualifying information (electronic bk.)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 9781118494882
Qualifying information (electronic bk.)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 1118494881
Qualifying information (electronic bk.)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
Cancelled/invalid ISBN 9781118396612
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
Cancelled/invalid ISBN 1118396618
028 01 - PUBLISHER NUMBER
Publisher number EB00063750
Source Recorded Books
029 1# - (OCLC)
OCLC library identifier CHBIS
System control number 010259671
029 1# - (OCLC)
OCLC library identifier CHVBK
System control number 325941866
029 1# - (OCLC)
OCLC library identifier DEBBG
System control number BV041049284
029 1# - (OCLC)
OCLC library identifier DEBBG
System control number BV041070263
029 1# - (OCLC)
OCLC library identifier DEBBG
System control number BV041908800
029 1# - (OCLC)
OCLC library identifier DEBSZ
System control number 431281912
029 1# - (OCLC)
OCLC library identifier NZ1
System control number 15916132
029 1# - (OCLC)
OCLC library identifier DEBBG
System control number BV043395276
035 ## - SYSTEM CONTROL NUMBER
System control number (OCoLC)823645667
Canceled/invalid control number (OCoLC)823726452
-- (OCoLC)864914126
043 ## - GEOGRAPHIC AREA CODE
Geographic area code n-us---
050 #4 - LIBRARY OF CONGRESS CALL NUMBER
Classification number RM302.5
Item number .B76 2013eb
060 #4 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER
Classification number QV 26.5
072 #7 - SUBJECT CATEGORY CODE
Subject category code MED
Subject category code subdivision 012000
Source bisacsh
082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 615.5/8
Edition number 23
049 ## - LOCAL HOLDINGS (OCLC)
Holding library MAIN
100 1# - MAIN ENTRY--PERSONAL NAME
Personal name Brown, Michael A.,
Dates associated with a name 1945-
245 12 - TITLE STATEMENT
Title A history of a cGMP medical event investigation /
Statement of responsibility, etc Michael A. Brown.
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT)
Place of publication, distribution, etc Hoboken, N.J. :
Name of publisher, distributor, etc John Wiley & Sons,
Date of publication, distribution, etc ©2013.
300 ## - PHYSICAL DESCRIPTION
Extent 1 online resource.
336 ## -
-- text
-- txt
-- rdacontent
337 ## -
-- computer
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-- rdamedia
338 ## -
-- online resource
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-- rdacarrier
520 ## - SUMMARY, ETC.
Summary, etc Beginning with the untimely death of a young mother, A History of a cGMP Medical Event Investigation unfolds a fictitious case study that captures how unchecked human flaws during the development and launch of a new drug can lead to disastrous consequences. Moreover, it illustrates how and why Six Sigma principles and methods should be applied to fully comply with FDA regulations at every stage of drug development and commercialization. From initial transgenic mouse studies to the FDA fatality investigation, this case study introduces all the key regulations and practices that govern the development, manufacture, and marketing of a new drug, including: [1] FDA Investigational and New Drug Application Processes, [2] FDA Code of Federal Regulations' current Good Manufacturing Practice (cGMP), [3] ISPE Good Automated Manufacturing Practice (GAMP) Readers will also be introduced to a variety of managers and researchers whose personal agendas conflict with best practices and therefore compromise the safety and effectiveness of a new drug product. Throughout the case study, the author offers tested and proven practices and tips so that these human flaws are not translated into drug product flaws. These practices and tips are critical and typically can only be learned through years of experience working in competitive drug development environments. A History of a cGMP Medical Event Investigation is ideal for students in biotechnology, pharmacology, engineering, and business management as well as professionals in biomedical and drug development. All readers will discover what can go wrong in developing and bringing a new drug to market. Most importantly, they will also learn how to apply Six Sigma principles and methods to ensure safe and effective product design, development, and manufacturing.
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc Includes bibliographical references and index.
588 0# -
-- Print version record.
505 0# - FORMATTED CONTENTS NOTE
Formatted contents note Title page; Copyright page; Dedication; Contents; Preface; ***; PART ONE: The Event; 1: Francesca; ***; PART TWO: Drug Discovery:Five Years Earlier; 2: Katlin BioScience: Transgenic Mouse Study; 3: Oxy-Fox Inhaler; 3.1 Kinnen Laboratories; 3.2 Kinnen Laboratories: Oxy-Fox Transfer; 3.3 Due-Diligence Team and Katlin Data Acceptance; PART THREE: Kinnen Oxy-Fox Inhaler Market Launch Program; 4: Agency IND and NDA Requirements, Six Sigma Charter, and Device Master Record; 4.1 Launch Team Meeting Number 1; ***; ***; ***; 4.2 Meeting with Medical Affairs: Toxicity Studies.
505 8# - FORMATTED CONTENTS NOTE
Formatted contents note 5: Meeting Minutes Guidelines5.1 Launch Team Meeting Number 2; ***; 6: Project Timing, Marketing Plan, and 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; 7: cGMP Process Validation Requirements; 7.1 Launch Team Meeting Number 4; ***; 8: Failure Mode Effects Analysis; 8.1 Launch Team Meeting Number 5; ***; 9: Design for Manufacturability, Design for Six Sigma, Concurrent Design; 9.1 Product Development Meeting Number 1; ***
505 8# - FORMATTED CONTENTS NOTE
Formatted contents note 9.2 Update Meeting with Ed Chase and Gordon Taylor10: Design Fishbone Diagram; 10.1 Launch Team Meeting Number 6; 11: Product Specifications; 11.1 Product Development Meeting Number 2; 12: Design Control; 12.1 Design Team Meeting Number 7; 12.2 Product Development Staff Meeting; 12.3 Engineering One-on-One; 12.4 Program Update; 13: Design of Experiments (DOE); 13.1 Molding Team Meeting; 14: Start-Up Issues; 14.1 Oxy-Fox Inhaler Wrap-Up and Equipment Start-Up; ***; 14.2 The Final Management Review; ***; PART FOUR: Present Day: Funeral; 15: Grief; ***; 16: The Autopsy Results; ***
505 8# - FORMATTED CONTENTS NOTE
Formatted contents note 17: The Agency***; ***; PART FIVE: Agency Medical Event Letter; 18: Kinnen Notification; 18.1 Another Agency Letter; 18.2 Medical Event Review Meeting; ***; 19: Investigation Team Management; 19.1. Morning Meeting with Gail Strom, Marcia Hines, and Dan Garvey; 20: DMAIC Investigation Process; 21: Internal Quality Review; 21.1 Meeting with Gail Strom and Marcia Hines; 21.2 Executive Management Review; ***; ***; ***; 22: The Agency Audit Letter; ***; 23: Agency Arrival; ***; 24: The Audit.
505 8# - FORMATTED CONTENTS NOTE
Formatted contents note 24.1 Agency Meeting to Review Qualification Documents and the Quality Acceptance Records of First Lot to Stock***; 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; ***; 25: End-of-Day Agency Wrap-Up Meeting; ***; 26: Kinnen Management Review; ***; ***; PART SIX: Reckoning; 27: Blame and Responsibility; 27.1 The Investigation Is a Public Record; 27.2 Kinnen Wrap-Up; ***
526 ## - STUDY PROGRAM INFORMATION NOTE
Department Biotechnology & Bioinformatics
610 10 - SUBJECT ADDED ENTRY--CORPORATE NAME
Corporate name or jurisdiction name as entry element United States.
Subordinate unit Food and Drug Administration.
610 17 - SUBJECT ADDED ENTRY--CORPORATE NAME
Corporate name or jurisdiction name as entry element United States.
Subordinate unit Food and Drug Administration.
Source of heading or term fast
-- (OCoLC)fst00549734
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Drugs
General subdivision Side effects.
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Adverse Drug Reaction Reporting Systems.
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Drug Therapy
General subdivision adverse effects.
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Investigational New Drug Application.
651 #2 - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Geographic name United States.
650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Adverse Drug Reaction Reporting Systems
Geographic subdivision United States.
650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Drug Therapy
General subdivision adverse effects
Geographic subdivision United States.
650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Investigational New Drug Application
Geographic subdivision United States.
650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element United States.
650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element United States.
General subdivision Food and drug administration.
650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element MEDICAL
General subdivision Chemotherapy.
Source of heading or term bisacsh
650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Drugs
General subdivision Side effects.
Source of heading or term fast
-- (OCoLC)fst00898912
655 #4 - INDEX TERM--GENRE/FORM
Genre/form data or focus term Electronic books.
776 08 - ADDITIONAL PHYSICAL FORM ENTRY
Display text Print version:
Main entry heading Brown, Michael A., 1945-
Title History of a cGMP medical event investigation.
Place, publisher, and date of publication Hoboken, N.J. : John Wiley & Sons, ©2013
International Standard Book Number 9781118396612
Record control number (DLC) 2012027158
-- (OCoLC)800720504
856 40 - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier <a href="http://dx.doi.org/10.1002/9781118494943">http://dx.doi.org/10.1002/9781118494943</a>
Public note Wiley Online Library
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-- 92
-- DG1

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