A Brown, Michael A. 1945- creator text bibliography Electronic books. nju Hoboken, N.J John Wiley & Sons ©2013 2013 monographic eng

electronic resource

1 online resource. 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. 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. 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; *** 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; *** 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. 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; *** Michael A. Brown. Includes bibliographical references and index. n-us--- United States. Food and Drug Administration. United States. Food and Drug Administration. Drugs Side effects Adverse Drug Reaction Reporting Systems Drug Therapy adverse effects Investigational New Drug Application Adverse Drug Reaction Reporting Systems United States Drug Therapy adverse effects United States Investigational New Drug Application United States United States United States Food and drug administration MEDICAL Chemotherapy Drugs Side effects United States RM302.5 .B76 2013eb 615.5/8 QV 26.5 Brown, Michael A., 1945- Hoboken, N.J. : John Wiley & Sons, ©2013 (DLC) 2012027158 (OCoLC)800720504 9781118494943 1118494946 9781118494936 1118494938 9781118494882 1118494881 EB00063750 Recorded Books http://onlinelibrary.wiley.com/book/10.1002/9781118494943 http://onlinelibrary.wiley.com/book/10.1002/9781118494943 N$T 130108 20171112122723.0 ocn823645667 eng