a history of a cgmp medical event investigation

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A History Of A Cgmp Medical Event Investigation

Author : Michael A. Brown
ISBN : 9781118494882
Genre : Technology & Engineering
File Size : 82. 79 MB
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Case study details the right way and the wrong way to successfully develop and market a new drug 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: FDA Investigational and New Drug Application Processes FDA Code of Federal Regulations' current Good Manufacturing Practice (cGMP) 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.

Establishing A Cgmp Laboratory Audit System

Author : David M. Bliesner
ISBN : 9780471784777
Genre : Science
File Size : 68. 83 MB
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The first systematic, hands-on auditing guide for today's pharmaceutical laboratories In today's litigious environment, pharmaceutical laboratories are subject to ever stricter operational guidelines as mandated by the FDA, and must be able to establish and demonstrate sustainable operational practices that ensure compliance with the current good manufacturing practice (CGMP) regulations. David Bliesner's Establishing a CGMP Laboratory Audit System: A Practical Guide is designed to provide laboratory supervisors and personnel with a step-by-step, hands-on audit system that they can rely on to ensure their facility remains compliant with all current and future requirements. Focusing on a "team approach," the author uses detailed flowcharts, checklists, and descriptions of the auditing process to help readers develop a new audit system or upgrade their current system in order to: * Improve current compliance * Demonstrate sustainable compliance * Produce data for federal inspections * Avoid regulatory action Enhanced with detailed checklists and a wealth of practical and flexible auditing tools on CD-ROM, this book provides an ideal resource for new and future laboratory personnel, and an excellent means for keeping existing industry practitioners up to date on the nuances of operating a consistently compliant pharmaceutical laboratory.

Predictive Admet

Author : Jianling Wang
ISBN : 9781118783306
Genre : Medical
File Size : 41. 55 MB
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Quality Assurance Of Pharmaceuticals

Author : World Health Organization
ISBN : 9789241547086
Genre : Health & Fitness
File Size : 41. 92 MB
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Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard, spurious and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel. Many of the relevant documents endorsed by the Committee are reproduced in this volume providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value to those working in faculties of pharmacy, in medicines regulation and control and in the pharmaceutical industry. This is the second updated edition of the compendium and includes texts published in 2005 and 2006 in the WHO Technical Report Series.

Medical Device Regulations

Author : World Health Organization
ISBN : 9241546182
Genre : Medical
File Size : 49. 77 MB
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The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.

Drug Injury

Author : James O'Donnell (Pharm. D.)
ISBN : 9780913875278
Genre : Law
File Size : 83. 65 MB
Format : PDF, Docs
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If you have an involvement with the health care system, you know that drug-induced injury cases are as complex as they are common. While the injury to the patient might seem obvious, in reality that has very little effect on the course that the litigation will take. This makes it especially important to accurately evaluate the case. You'll want to be sure that the case you take on has merit and will prove economically sound for both you and your client. To successfully accomplish this, you need the knowledge of pharmacy and the drug manufacturing industry that the authors have carefully detailed in this book.Easy for the nonmedical professional to follow, the book is divided into three useful sections. The first section deals with the pharmaceutical process, covering the liability of pharmaceutical companies, warning labels and clinical trials. The second section examines high-risk drug therapies that result in pharmaceutical litigation. You'll read about important litigation regarding drugs like Prozac, Accutane and Rezulin, as well as anabolic steroids, insulin and oral diabetic drugs, and more. Whether or not your case involves the drug cited you'll find that the theories applicable to one pharmaceutical case are often applicable to another. The third section of the book looks at the professional pharmacist and malpractice claims. It also includes appendices of FDA regulations relating to drug product liability, guidance for industry, use of risk minimization plans, and FDA pregnancy classifications.You'll find this text indispensable because it provides comprehensive information for all those affiliated with the pharmaceutical industry.New chapters: The failed system of drug warnings in America Clinical research: Testing treatments in humans FDA regulation of clinical investigations Identification of regulated solid dosage forms Evaluation of Causation in drug injury cases The role of pharmacoepidemiology and expert testimony in drug injury E-ferol disaster Drugs for asthma, allerfies and anaphylaxis: Harm from use, misuse and non-use Nephrotoxic drugs Statins and Baycol-Questionable cholesterol The Rezulin litigation Drug-induced movement disorders Ephedra The emergency department pharmacist Drug testing in the workplace


Author : World Health Organization
ISBN : 9789241547550
Genre : Medical
File Size : 81. 46 MB
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Good laboratory practices (GLP) are the recognized rules governing the conduct of non-clinical safety studies. They ensure the quality, integrity and reliability of the study data. This handbook is designed as an aid for those countries wishing to upgrade their laboratories to GLP status. Based on the Organisation for Economic Cooperation and Development (OECD) principles of GLP, The aim of the handbook is to provide laboratories and trainers in disease-endemic countries with the necessary technical information for implementing GLP programmes. The material in the handbook is presented in a clear and informative way. The introduction reviews the need for quality standards in drug research and development, and gives a history of GLP. Chapter 2 covers GLP training, and chapter 3, The stepwise introduction of GLP. The OECD principles of GLP and compliance monitoring are reprinted, with kind permission, In the annex section

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