{"product_id":"a-history-of-a-cgmp-medical-event-investigation-isbn-9781118396612","title":"A History of a cGMP Medical Event Investigation","description":"\u003cp\u003e\u003cb\u003eCase study details the right way and the wrong way to successfully develop and market a new drug\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eBeginning with the untimely death of a young mother, \u003ci\u003eA History of a cGMP Medical Event Investigation\u003c\/i\u003e 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.\u003c\/p\u003e \u003cp\u003eFrom 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:\u003c\/p\u003e \u003cul\u003e \u003cli\u003eFDA Investigational and New Drug Application Processes\u003c\/li\u003e \u003cli\u003eFDA Code of Federal Regulations' current Good Manufacturing Practice (cGMP)\u003c\/li\u003e \u003cli\u003eISPE Good Automated Manufacturing Practice (GAMP)\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eReaders 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.\u003c\/p\u003e \u003cp\u003e\u003ci\u003eA History of a cGMP Medical Event Investigation\u003c\/i\u003e 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.\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePreface xi\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart One The Event 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Francesca 3\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart Two Drug Discovery: Five Years Earlier 9\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Katlin Bioscience: Transgenic Mouse Study 11\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Oxy-Fox Inhaler 21\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e3.1 Kinnen Laboratories 21\u003c\/p\u003e \u003cp\u003e3.2 Kinnen Laboratories: Oxy-Fox Transfer 22\u003c\/p\u003e \u003cp\u003e3.3 Due-Diligence Team and Katlin Data Acceptance 23\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart Three Kinnen Oxy-Fox Inhaler Market Launch Program 25\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Agency IND and NDA Requirements, Six Sigma Charter, and Device Master Record 27\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4.1 Launch Team Meeting Number 1 27\u003c\/p\u003e \u003cp\u003e4.2 Meeting with Medical Affairs: Toxicity Studies 46\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Meeting Minutes Guidelines 49\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e5.1 Launch Team Meeting Number 2 49\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Project Timing, Marketing Plan, and Offshore Molding 55\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e6.1 Launch Team Meeting Number 3 55\u003c\/p\u003e \u003cp\u003e6.2 Project Financial Review 61\u003c\/p\u003e \u003cp\u003e6.3 Progress Meeting: Who Takes Credit for What? 64\u003c\/p\u003e \u003cp\u003e6.4 Morning Meeting: Just-in-Time Manufacturing 65\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 cGMP Process Validation Requirements 69\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e7.1 Launch Team Meeting Number 4 69\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Failure Mode Effects Analysis 81\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e8.1 Launch Team Meeting Number 5 81\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Design for Manufacturability, Design for Six Sigma, Concurrent Design 93\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e9.1 Product Development Meeting Number 1 93\u003c\/p\u003e \u003cp\u003e9.2 Update Meeting with Ed Chase and Gordon Taylor 102\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Design Fishbone Diagram 105\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e10.1 Launch Team Meeting Number 6 105\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Product Specifications 111\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e11.1 Product Development Meeting Number 2 111\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Design Control 115\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e12.1 Design Team Meeting Number 7 115\u003c\/p\u003e \u003cp\u003e12.2 Product Development Staff Meeting 118\u003c\/p\u003e \u003cp\u003e12.3 Engineering One-on-One 119\u003c\/p\u003e \u003cp\u003e12.4 Program Update 120\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Design of Experiments (DOE) 123\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e13.1 Molding Team Meeting 123\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 Start-Up Issues 129\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e14.1 Oxy-Fox Inhaler Wrap-Up and Equipment Start-Up 129\u003c\/p\u003e \u003cp\u003e14.2 The Final Management Review 135\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart Four Present Day: Funeral 139\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15 Grief 141\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e16 The Autopsy Results 145\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e17 The Agency 151\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart Five Agency Medical Event Letter 155\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e18 Kinnen Notification 157\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e18.1 Another Agency Letter 157\u003c\/p\u003e \u003cp\u003e18.2 Medical Event Review Meeting 158\u003c\/p\u003e \u003cp\u003e\u003cb\u003e19 Investigation Team Management 161\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e19.1. Morning Meeting with Gail Strom, Marcia Hines, and Dan Garvey 161\u003c\/p\u003e \u003cp\u003e\u003cb\u003e20 DMAIC Investigation Process 163\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e21 Internal Quality Review 171\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e21.1 Meeting with Gail Strom and Marcia Hines 171\u003c\/p\u003e \u003cp\u003e21.2 Executive Management Review 174\u003c\/p\u003e \u003cp\u003e\u003cb\u003e22 The Agency Audit Letter 179\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e23 Agency Arrival 183\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e24 The Audit 187\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e24.1 Agency Meeting to Review Qualification Documents and the Quality Acceptance Records of First Lot to Stock 187\u003c\/p\u003e \u003cp\u003e24.2 Agency Meeting to Review the Oxy-Fox Inhaler Lot Used in the NDA Clinical Studies 189\u003c\/p\u003e \u003cp\u003e24.3 Agency Meeting to Review the Design and Program Team Meeting Minutes 190\u003c\/p\u003e \u003cp\u003e24.4 Agency Meeting to Review the Due-Diligence Report Katlin Studies, and Oxy-Fox Design History File, 192\u003c\/p\u003e \u003cp\u003e\u003cb\u003e25 End-of-Day Agency Wrap-Up Meeting 197\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e26 Kinnen Management Review 201\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart Six Reckoning 207\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e27 Blame and Responsibility 209\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e27.1 The Investigation Is a Public Record 209\u003c\/p\u003e \u003cp\u003e27.2 Kinnen Wrap-Up 210\u003c\/p\u003e \u003cp\u003e\u003cb\u003e28 Closure 213\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eBibliography 215\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eIndex 217\u003c\/b\u003e\u003c\/p\u003e  \u003cp\u003e\u003cb\u003eMICHAEL A. BROWN, PhD, PE,\u003c\/b\u003e is a Visiting Professor at the University of Illinois at Chicago. Dr. Brown has twenty-five years' experience in the biomedical industry in a product and process design capacity with responsibilities for worldwide engineering and management. He has served as a lead engineer on numerous products, process, and equipment projects including design, implementation, and qualifications. He is a registered Professional Engineer and a certified Six Sigma Black Belt with considerable experience in team leadership. The material presented in this case, including the FDA regulations and Six Sigma concepts, was tested in an engineering senior design course taught by Dr. Brown over a three-year period. Student feedback noted that the difficult design principles were explained in an easy-to-read story that introduced them to the Six Sigma methodologies in an engaging manner.\u003c\/p\u003e  \u003cp\u003e\u003cb\u003eCase study details the right way and the wrong way to successfully develop and market a new drug\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eBeginning with the untimely death of a young mother, \u003ci\u003eA History of a cGMP Medical Event Investigation\u003c\/i\u003e 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.\u003c\/p\u003e \u003cp\u003eFrom 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:\u003c\/p\u003e \u003cul\u003e \u003cli\u003eFDA Investigational and New Drug Application Processes\u003c\/li\u003e \u003cli\u003eFDA Code of Federal Regulations' current Good Manufacturing Practice (cGMP)\u003c\/li\u003e \u003cli\u003eISPE Good Automated Manufacturing Practice (GAMP)\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eReaders 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.\u003c\/p\u003e \u003cp\u003e\u003ci\u003eA History of a cGMP Medical Event Investigation\u003c\/i\u003e 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.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47988632453349,"sku":"NP9781118396612","price":51.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781118396612.jpg?v=1761781049","url":"https:\/\/k12savings.com\/es\/products\/a-history-of-a-cgmp-medical-event-investigation-isbn-9781118396612","provider":"K12savings","version":"1.0","type":"link"}