A history of a cGMP medical event investigation / (Record no. 63828)
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| 001 - CONTROL NUMBER | |
| control field | sulb-eb0032176 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | BD-SySUS |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20170713221323.0 |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS | |
| 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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| -- | CDX |
| -- | IDEBK |
| -- | OCLCA |
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| 019 ## - | |
| -- | 823726452 |
| -- | 864914126 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781118494943 |
| Qualifying information | (electronic bk.) |
| International Standard Book Number | 1118494946 |
| Qualifying information | (electronic bk.) |
| International Standard Book Number | 9781118494936 |
| Qualifying information | (electronic bk.) |
| International Standard Book Number | 1118494938 |
| Qualifying information | (electronic bk.) |
| International Standard Book Number | 9781118494882 |
| Qualifying information | (electronic bk.) |
| International Standard Book Number | 1118494881 |
| Qualifying information | (electronic bk.) |
| Canceled/invalid ISBN | 9781118396612 |
| Canceled/invalid ISBN | 1118396618 |
| 028 01 - PUBLISHER NUMBER | |
| Publisher number | EB00063750 |
| Source | Recorded Books |
| 029 1# - OTHER SYSTEM CONTROL NUMBER (OCLC) | |
| OCLC library identifier | CHBIS |
| System control number | 010259671 |
| OCLC library identifier | CHVBK |
| System control number | 325941866 |
| OCLC library identifier | DEBBG |
| System control number | BV041049284 |
| OCLC library identifier | DEBBG |
| System control number | BV041070263 |
| OCLC library identifier | DEBBG |
| System control number | BV041908800 |
| OCLC library identifier | DEBSZ |
| System control number | 431281912 |
| OCLC library identifier | NZ1 |
| System control number | 15916132 |
| 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 ## - CONTENT TYPE | |
| Content type term | text |
| Content type code | txt |
| Source | rdacontent |
| 337 ## - MEDIA TYPE | |
| Media type term | computer |
| Media type code | c |
| Source | rdamedia |
| 338 ## - CARRIER TYPE | |
| Carrier type term | online resource |
| Carrier type code | cr |
| Source | 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# - SOURCE OF DESCRIPTION NOTE | |
| Source of description note | 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. |
| 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; *** |
| 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; *** |
| 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. |
| 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; *** |
| 610 10 - SUBJECT ADDED ENTRY--CORPORATE NAME | |
| Corporate name or jurisdiction name as entry element | United States. |
| Subordinate unit | Food and Drug Administration. |
| Corporate name or jurisdiction name as entry element | United States. |
| Subordinate unit | Food and Drug Administration. |
| Source of heading or term | fast |
| Authority record control number | (OCoLC)fst00549734 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Drugs |
| General subdivision | Side effects. |
| Topical term or geographic name as entry element | Adverse Drug Reaction Reporting Systems. |
| Topical term or geographic name as entry element | Drug Therapy |
| General subdivision | adverse effects. |
| 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. |
| Topical term or geographic name as entry element | Drug Therapy |
| General subdivision | adverse effects |
| Geographic subdivision | United States. |
| Topical term or geographic name as entry element | Investigational New Drug Application |
| Geographic subdivision | United States. |
| Topical term or geographic name as entry element | United States. |
| Topical term or geographic name as entry element | United States. |
| General subdivision | Food and drug administration. |
| Topical term or geographic name as entry element | MEDICAL |
| General subdivision | Chemotherapy. |
| Source of heading or term | bisacsh |
| Topical term or geographic name as entry element | Drugs |
| General subdivision | Side effects. |
| Source of heading or term | fast |
| Authority record control number | (OCoLC)fst00898912 |
| 655 #4 - INDEX TERM--GENRE/FORM | |
| Genre/form data or focus term | Electronic books. |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | 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://onlinelibrary.wiley.com/book/10.1002/9781118494943">http://onlinelibrary.wiley.com/book/10.1002/9781118494943</a> |
| Public note | Wiley Online Library [Free Download only for SUST IP] |
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