000			07621cam a2200829Ia 4500
001			ocn823645667
003			OCoLC
005			20230823095612.0
006			m o d
007			cr cnu---unuuu
008			130108s2013 nju ob 001 0 eng d
040			_aN$T _beng _epn _cN$T _dYDXCP _dE7B _dCDX _dIDEBK _dOCLCA _dORE _dRECBK _dOCLCO _dDG1 _dUKDOC _dOCLCF _dCHVBK _dOCLCA _dEBLCP _dDEBSZ _dOCLCQ _dDEBBG
019			_a823726452 _a864914126
020			_a9781118494943 _q(electronic bk.)
020			_a1118494946 _q(electronic bk.)
020			_a9781118494936 _q(electronic bk.)
020			_a1118494938 _q(electronic bk.)
020			_a9781118494882 _q(electronic bk.)
020			_a1118494881 _q(electronic bk.)
020			_z9781118396612
020			_z1118396618
028	0	1	_aEB00063750 _bRecorded Books
029	1		_aCHBIS _b010259671
029	1		_aCHVBK _b325941866
029	1		_aDEBBG _bBV041049284
029	1		_aDEBBG _bBV041070263
029	1		_aDEBBG _bBV041908800
029	1		_aDEBSZ _b431281912
029	1		_aNZ1 _b15916132
029	1		_aDEBBG _bBV043395276
035			_a(OCoLC)823645667 _z(OCoLC)823726452 _z(OCoLC)864914126
043			_an-us---
050		4	_aRM302.5 _b.B76 2013eb
060		4	_aQV 26.5
072		7	_aMED _x012000 _2bisacsh
082	0	4	_a615.5/8 _223
049			_aMAIN
100	1		_aBrown, Michael A., _d1945-
245	1	2	_aA history of a cGMP medical event investigation / _cMichael A. Brown.
260			_aHoboken, N.J. : _bJohn Wiley & Sons, _c©2013.
300			_a1 online resource.
336			_atext _btxt _2rdacontent
337			_acomputer _bc _2rdamedia
338			_aonline resource _bcr _2rdacarrier
520			_aBeginning 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			_aIncludes bibliographical references and index.
588	0		_aPrint version record.
505	0		_aTitle 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		_a5: 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		_a9.2 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		_a17: 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		_a24.1 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	1	0	_aUnited States. _bFood and Drug Administration.
610	1	7	_aUnited States. _bFood and Drug Administration. _2fast _0(OCoLC)fst00549734
650		0	_aDrugs _xSide effects.
650		2	_aAdverse Drug Reaction Reporting Systems.
650		2	_aDrug Therapy _xadverse effects.
650		2	_aInvestigational New Drug Application.
651		2	_aUnited States.
650		4	_aAdverse Drug Reaction Reporting Systems _zUnited States.
650		4	_aDrug Therapy _xadverse effects _zUnited States.
650		4	_aInvestigational New Drug Application _zUnited States.
650		4	_aUnited States.
650		4	_aUnited States. _xFood and drug administration.
650		7	_aMEDICAL _xChemotherapy. _2bisacsh
650		7	_aDrugs _xSide effects. _2fast _0(OCoLC)fst00898912
655		4	_aElectronic books.
776	0	8	_iPrint version: _aBrown, Michael A., 1945- _tHistory of a cGMP medical event investigation. _dHoboken, N.J. : John Wiley & Sons, ©2013 _z9781118396612 _w(DLC) 2012027158 _w(OCoLC)800720504
856	4	0	_uhttp://dx.doi.org/10.1002/9781118494943 _zWiley Online Library
994			_a92 _bDG1
999			_c19995 _d19954
526			_bbtbi