Implementing A Curriculum For Improving Accuracy Of Real Time Comments In Electronic Batch Records For Genentech Inc

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Implementing a Curriculum for Improving Accuracy of Real-time Comments in Electronic Batch Records for Genentech, Inc

Author : Kirstie Hunt
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (99 download)

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Book Synopsis Implementing a Curriculum for Improving Accuracy of Real-time Comments in Electronic Batch Records for Genentech, Inc by : Kirstie Hunt

Download or read book Implementing a Curriculum for Improving Accuracy of Real-time Comments in Electronic Batch Records for Genentech, Inc written by Kirstie Hunt and published by . This book was released on 2017 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Genentech is a biopharmaceutical company located in Oceanside, CA. The Oceanside campus is one of five locations within the United States and is a multi-product drug substance Manufacturing facility of biopharmaceuticals. The Manufacturing production plant is controlled by an automated system called DeltaV, which facilitates the processing equipment to effectively produce biopharmaceuticals. DeltaV has the ability to track any process recordable including: alarms, holds/restart, overrides, and process interventions; simultaneously recording them to an Electronic Batch Record (EBR). In addition to the automated control system, Manufacturing bioprocess technicians provide manual support and oversight for the process operations and equipment. There are a multitude of Standard Operating Procedures (SOP), work instructions, training modules, instructor-led courses and other tools that provide guidelines and information for employees to perform compliant operations. EBRs are official Good Manufacturing Practice (GMP) documents that provide an audit trail for all manufacturing processes. The EBR is segmented into different sections including: material usage, equipment usage, batch formula, procedure details, phase details, failure messages, alarms, and process interventions. The EBR is generated real-time while a process recipe is running in DeltaV and populates the information to the Manufacturing Execution System (MES) or Syncade. Completed EBRs are compiled into the MES queue and undergo Manufacturing Quality Assurance (MQA) review, Manufacturing review, MQA approval and then become archived once the process is complete. Each step within the review process is tedious and time consuming, requiring acquisition of relevant information and a high degree of patience and technical accuracy to ensure the job is done correctly. It is the responsibility of MQA to make note of any issues, inconsistencies, or missing components within the completed record. It is the responsibility of the Manufacturing Department to address MQA's instructions with an appropriate comment. This review process is prolonged if comments are not entered real-time, thus generating more time in the review process and extensive investigation. There are a number of EBRs that require rework, which adds complexity, time, and non-value to the operations, thus costing Genentech money by impacting lot disposition and ultimately patients receipt of medication in a timely manner. Genentech would like to codify a solution for technicians to compose right the first time comments that are written real-time and reduce the percentage of batch records that are not completed correctly. This project aims to successfully analyze and implement a resourceful solution to the issue at hand. The DMAIC approach was conducted in order to identify and analyze the contributing elements that pose a threat to right the first time batch records. The DMAIC model is comprised of the following components: Define, Measure, Analyze, Improve and Control. The DMAIC approach is highlighted as a core component to the Six Sigma methodology, which is widely used as an industry standard. Six Sigma is a disciplined methodology for eliminating defects in Genentech's manufacturing process. The utilization of this concept has allowed for a development and implementation of an instructor-led training curriculum titled Right the First Time Comments Training. The idea of incorporating an instructor-led training course stemmed from studies stating it was a more effective and engaging method of encoding the content to trainees. Reportedly, 70% of learning comes from on the job practice (Heathfield, 2016), thus guiding the instructor-led training course to incorporate a variety of real life simulations that engage the attention of the trainees. The objective of the training course is to teach technicians how to write batch comments that are right the first time in order to avoid mistakes that may cause unnecessary re-work and delays. Upon completion of this course technicians will be equipped to navigate through MES/Syncade and DeltaV, locate in-process batch records, utilize process historian, identify SOP linkages, and properly write a comment.

Genentech

Author : Sally Smith Hughes
Publisher : University of Chicago Press
ISBN 13 : 0226359204
Total Pages : 231 pages
Book Rating : 4.2/5 (263 download)

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Book Synopsis Genentech by : Sally Smith Hughes

Download or read book Genentech written by Sally Smith Hughes and published by University of Chicago Press. This book was released on 2011-09-21 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the fall of 1980, Genentech, Inc., a little-known California genetic engineering company, became the overnight darling of Wall Street, raising over $38 million in its initial public stock offering. Lacking marketed products or substantial profit, the firm nonetheless saw its share price escalate from $35 to $89 in the first few minutes of trading, at that point the largest gain in stock market history. Coming at a time of economic recession and declining technological competitiveness in the United States, the event provoked banner headlines and ignited a period of speculative frenzy over biotechnology as a revolutionary means for creating new and better kinds of pharmaceuticals, untold profit, and a possible solution to national economic malaise. Drawing from an unparalleled collection of interviews with early biotech players, Sally Smith Hughes offers the first book-length history of this pioneering company, depicting Genentech’s improbable creation, precarious youth, and ascent to immense prosperity. Hughes provides intimate portraits of the people significant to Genentech’s science and business, including cofounders Herbert Boyer and Robert Swanson, and in doing so sheds new light on how personality affects the growth of science. By placing Genentech’s founders, followers, opponents, victims, and beneficiaries in context, Hughes also demonstrates how science interacts with commercial and legal interests and university research, and with government regulation, venture capital, and commercial profits. Integrating the scientific, the corporate, the contextual, and the personal, Genentech tells the story of biotechnology as it is not often told, as a risky and improbable entrepreneurial venture that had to overcome a number of powerful forces working against it.

Pharmaceutical Manufacturing Handbook

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
ISBN 13 : 0470259809
Total Pages : 1384 pages
Book Rating : 4.4/5 (72 download)

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Book Synopsis Pharmaceutical Manufacturing Handbook by : Shayne Cox Gad

Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-03-21 with total page 1384 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.

Introduction to Business

Author : Lawrence J. Gitman
Publisher :
ISBN 13 :
Total Pages : 1455 pages
Book Rating : 4./5 ( download)

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Book Synopsis Introduction to Business by : Lawrence J. Gitman

Download or read book Introduction to Business written by Lawrence J. Gitman and published by . This book was released on 2024-09-16 with total page 1455 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introduction to Business covers the scope and sequence of most introductory business courses. The book provides detailed explanations in the context of core themes such as customer satisfaction, ethics, entrepreneurship, global business, and managing change. Introduction to Business includes hundreds of current business examples from a range of industries and geographic locations, which feature a variety of individuals. The outcome is a balanced approach to the theory and application of business concepts, with attention to the knowledge and skills necessary for student success in this course and beyond. This is an adaptation of Introduction to Business by OpenStax. You can access the textbook as pdf for free at openstax.org. Minor editorial changes were made to ensure a better ebook reading experience. Textbook content produced by OpenStax is licensed under a Creative Commons Attribution 4.0 International License.

The Startup of You (Revised and Updated)

Author : Reid Hoffman
Publisher : Crown Currency
ISBN 13 : 0307888924
Total Pages : 274 pages
Book Rating : 4.3/5 (78 download)

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Book Synopsis The Startup of You (Revised and Updated) by : Reid Hoffman

Download or read book The Startup of You (Revised and Updated) written by Reid Hoffman and published by Crown Currency. This book was released on 2012-02-14 with total page 274 pages. Available in PDF, EPUB and Kindle. Book excerpt: The groundbreaking #1 New York Times bestseller that taught a generation how to transform their careers—now in a revised and updated edition “A profound book about self-determination and self-realization.”—Senator Cory Booker “The Startup of You is crammed with insights and strategies to help each of us create the work life we want.”—Gretchen Rubin, author of The Happiness Project In this invaluable book, LinkedIn co-founder Reid Hoffman and venture capitalist Ben Casnocha show how to accelerate your career in today’s competitive world. The key is to manage your career as if it were a startup business: a living, breathing, growing startup of you. Why? Startups—and the entrepreneurs who run them—are nimble. They invest in themselves. They build their professional networks. They take intelligent risks. They make uncertainty and volatility work to their advantage. These are the very same skills professionals need to get ahead today. This book isn’t about cover letters or résumés. Instead, you will learn the best practices of the most successful startups and how to apply these entrepreneurial strategies to your career. Whether you work for a giant multinational corporation, stitch together multiple gigs in a portfolio career, or are launching your own venture, you need to know how to • adapt your career plans as pandemics rage and technologies upend industries • develop a competitive advantage so that you stand out from others at work • strengthen your professional network by building powerful alliances and maintaining a diverse mix of relationships • engineer serendipity that produces life-changing career opportunities • take proactive risks to become more resilient to industry tsunamis • tap your network for information and intelligence that help you make smarter decisions The career landscape has changed dramatically in the decade since Hoffman and Casnocha first published this guide. In an urgent update to the frameworks that have helped hundreds of thousands of people transform their careers, this new edition of The Startup of You will teach you how to achieve your boldest professional ambitions.

Artificial Intelligence in Ophthalmology

Author : Andrzej Grzybowski
Publisher : Springer Nature
ISBN 13 : 3030786013
Total Pages : 280 pages
Book Rating : 4.0/5 (37 download)

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Book Synopsis Artificial Intelligence in Ophthalmology by : Andrzej Grzybowski

Download or read book Artificial Intelligence in Ophthalmology written by Andrzej Grzybowski and published by Springer Nature. This book was released on 2021-10-13 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a wide-ranging overview of artificial intelligence (AI), machine learning (ML) and deep learning (DL) algorithms in ophthalmology. Expertly written chapters examine AI in age-related macular degeneration, glaucoma, retinopathy of prematurity and diabetic retinopathy screening. AI perspectives, systems and limitations are all carefully assessed throughout the book as well as the technical aspects of DL systems for retinal diseases including the application of Google DeepMind, the Singapore algorithm, and the Johns Hopkins algorithm. Artificial Intelligence in Ophthalmology meets the need for a resource that reviews the benefits and pitfalls of AI, ML and DL in ophthalmology. Ophthalmologists, optometrists, eye-care workers, neurologists, cardiologists, internal medicine specialists, AI engineers and IT specialists with an interest in how AI can help with early diagnosis and monitoring treatment in ophthalmic patients will find this book to be an indispensable guide to an evolving area of healthcare technology.

Désiré Collen - Biotech Pioneer

Author : Paul Huybrechts
Publisher : Désiré Collen
ISBN 13 : 164999608X
Total Pages : 290 pages
Book Rating : 4.6/5 (499 download)

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Book Synopsis Désiré Collen - Biotech Pioneer by : Paul Huybrechts

Download or read book Désiré Collen - Biotech Pioneer written by Paul Huybrechts and published by Désiré Collen. This book was released on 2020-08-27 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: Désiré Collen, Biotech Pioneer relates the fascinating story of scientific discovery in a time when biotechnology was not yet a science. Although the cultivation and cross fertilization of plants were, strictly speaking, biotechnological techniques, modern biotechnology dates from the early 1970s, when pioneers such as biochemist Herbert Boyer from the university of California managed to transfer genetic material into a bacterium. Together with venture capitalist Robert Swanson, Boyer set up Genentech, one of the first genetic engineering companies. Just a few years later, on the other side of the Atlantic, in Leuven, Désiré Collen discovered t-PA, the enzyme responsible for fibrinolysis, or the dissolving of blood clots. Clogged arteries were then still one of the major causes of death. The ensuing cooperation between Collen and Genentech was the beginning of a long-lasting success story, from which not only Collen but also scientific research and the University of Leuven benefitted greatly for many years. According to a Reuters ranking, KU Leuven has been, from 2016 onwards, the most innovative university in Europe. Flanders and Belgium served as the cradle of several highly successful biotech companies. t-PA was a relatively expensive medicine, and Collen went on to develop a much cheaper clot-dissolving remedy to benefit patients in less affluent countries. He failed, however, to find the necessary finances for Phase 3 trials. Meanwhile, he had set up ThromboGenics, a company which later specialized in ophthalmology. Collen continued to stimulate and finance research in other fields, such as the cardiovascular research of Peter Carmeliet. In 2013 he left ThromboGenics, following a difference in views on the company’s focus, and in 2015 he set up Fund+, a biotech-oriented investment firm. Fund+ has meanwhile acquired a prominent place among European biotech investment funds and has scored some astonishing early successes. In June 2020, Fund+ had 13 companies in its portfolio, with several more waiting to come on board.

Frontiers in Chemical Engineering

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 030903793X
Total Pages : 236 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Frontiers in Chemical Engineering by : National Research Council

Download or read book Frontiers in Chemical Engineering written by National Research Council and published by National Academies Press. This book was released on 1988-02-01 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the next 10 to 15 years, chemical engineers have the potential to affect every aspect of American life and promote the scientific and industrial leadership of the United States. Frontiers in Chemical Engineering explores the opportunities available and gives a blueprint for turning a multitude of promising visions into realities. It also examines the likely changes in how chemical engineers will be educated and take their place in the profession, and presents new research opportunities.

Closing the Cancer Divide

Author : Felicia Knaul
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (137 download)

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Book Synopsis Closing the Cancer Divide by : Felicia Knaul

Download or read book Closing the Cancer Divide written by Felicia Knaul and published by . This book was released on 2013 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cancer has become a leading cause of death and disability and a serious yet unforeseen challenge to health systems in low-and middle-income countries. A protracted and polarized cancer transition is under way and fuels a concentration of preventable risk, illness, suffering, impoverishment from ill health, and death among poor populations. Closing this cancer divide is an equity imperative. The world faces a huge, unperceived cost of failure to take action that requires an immediate and large-scale global response. Closing the Cancer Divide presents strategies for innovation in delivery, pricing, procurement, finance, knowledge-building, and leadership that can be scaled up by applying a diagonal approach to health system strengthening. The chapters provide evidence-based recommendations for developing programs, local and global policy-making, and prioritizing research. The cases and frameworks provide a guide for developing responses to the challenge of cancer and other chronic illnesses. The book summarizes results of the Global Task Force on Expanding Access to Cancer Care and Control in Developing Countries, a collaboration among leaders from the global health and cancer care communities worldwide, originally convened by Harvard University. It includes contributions from civil society, global and national policy-makers, patients and practitioners, and academics representing an array of fields.

Writing the Laboratory Notebook

Author : Howard M. Kanare
Publisher :
ISBN 13 :
Total Pages : 168 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Writing the Laboratory Notebook by : Howard M. Kanare

Download or read book Writing the Laboratory Notebook written by Howard M. Kanare and published by . This book was released on 1985 with total page 168 pages. Available in PDF, EPUB and Kindle. Book excerpt: Describes in general how scientists can use handwritten research notebooks as a tool to record their research in progress, and in particular the legal protocols for industrial scientists to handwrite their research in progress so they can establish priority of invention in case a patent suit arises.

National Library of Medicine Programs and Services

Author : National Library of Medicine (U.S.)
Publisher :
ISBN 13 :
Total Pages : 88 pages
Book Rating : 4.:/5 (319 download)

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Book Synopsis National Library of Medicine Programs and Services by : National Library of Medicine (U.S.)

Download or read book National Library of Medicine Programs and Services written by National Library of Medicine (U.S.) and published by . This book was released on 1981 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Plant Biotechnology and Genetics

Author : C. Neal Stewart, Jr.
Publisher : John Wiley & Sons
ISBN 13 : 1118589483
Total Pages : 554 pages
Book Rating : 4.1/5 (185 download)

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Book Synopsis Plant Biotechnology and Genetics by : C. Neal Stewart, Jr.

Download or read book Plant Biotechnology and Genetics written by C. Neal Stewart, Jr. and published by John Wiley & Sons. This book was released on 2012-12-13 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt: Designed to inform and inspire the next generation of plant biotechnologists Plant Biotechnology and Genetics explores contemporary techniques and applications of plant biotechnology, illustrating the tremendous potential this technology has to change our world by improving the food supply. As an introductory text, its focus is on basic science and processes. It guides students from plant biology and genetics to breeding to principles and applications of plant biotechnology. Next, the text examines the critical issues of patents and intellectual property and then tackles the many controversies and consumer concerns over transgenic plants. The final chapter of the book provides an expert forecast of the future of plant biotechnology. Each chapter has been written by one or more leading practitioners in the field and then carefully edited to ensure thoroughness and consistency. The chapters are organized so that each one progressively builds upon the previous chapters. Questions set forth in each chapter help students deepen their understanding and facilitate classroom discussions. Inspirational autobiographical essays, written by pioneers and eminent scientists in the field today, are interspersed throughout the text. Authors explain how they became involved in the field and offer a personal perspective on their contributions and the future of the field. The text's accompanying CD-ROM offers full-color figures that can be used in classroom presentations with other teaching aids available online. This text is recommended for junior- and senior-level courses in plant biotechnology or plant genetics and for courses devoted to special topics at both the undergraduate and graduate levels. It is also an ideal reference for practitioners.

Entrepreneurship

Author : Marc J. Dollinger
Publisher :
ISBN 13 : 9780130909954
Total Pages : 0 pages
Book Rating : 4.9/5 (99 download)

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Book Synopsis Entrepreneurship by : Marc J. Dollinger

Download or read book Entrepreneurship written by Marc J. Dollinger and published by . This book was released on 2003 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: For junior/senior/graduate-level courses in Entrepreneurship, New Venture Creation, and Small Business Strategy. Based on the premise that entrepreneurship can be studied systematically, this text offers a comprehensive presentation of the best current theory and practice. It takes a resource-based point-of-view, showing how to acquire and use resources and assets for competitive advantage. FOCUS ON THE NEW ECONOMY * NEW-Use of the Internet-Integrated throughout with special treatment in Ch. 6. * Demonstrates to students how the new economy still follows many of the rigorous rules of economics, and gives them examples of business-to-business and business-to-customer firms so that they can build better business models. * NEW-2 added chapters on e-entrepreneurship-Covers value pricing; market segmentation; lock-in; protection of intellectual property; and network externalities. * Examines the new economy and the types of resources, capabilities, and strategies that are needed for success in the Internet world. * Resource-based theory-Introduced in Ch. 2 and revisited in each subsequent chapter to help tie concepts together. * Presents an overarching framework, and helps students focu

Comprehensive Pharmacy Review

Author : Leon Shargel
Publisher :
ISBN 13 : 9781451175745
Total Pages : 1472 pages
Book Rating : 4.1/5 (757 download)

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Book Synopsis Comprehensive Pharmacy Review by : Leon Shargel

Download or read book Comprehensive Pharmacy Review written by Leon Shargel and published by . This book was released on 2012-10-01 with total page 1472 pages. Available in PDF, EPUB and Kindle. Book excerpt: n In this completely updated 8th edition, Comprehensive Pharmacy Review for NAPLEX provides a complete knowledge base necessary for pharmacy students, instructors, foreign graduates, and professionals to excel in their practices--and be fully equipped to tackle the NAPLEX competency test. Updated to conform with USP 797 regulations, the text provides expanded coverage of ever-developing areas of practice, including pain management, hepatic disorders, migraines, women's health, prescription dermatologic agents, geriatrics, and pediatrics. More than 60 print and online chapters--spanning chemistry, pharmaceutics, pharmacology, pharmacy practice, and drug therapy--are presented in outline form for easy use and offer helpful practice questions to aid your study. Comprehensive Pharmacy Review provides guidelines and tips for taking the NAPLEX, along with the NAPLEX blueprint. Furthermore, it lists the actual competency statements that the National Association of Boards of Pharmacy (NABP) uses in evaluation.

Molecular Biotechnology

Author : Bernard R. Glick
Publisher :
ISBN 13 :
Total Pages : 724 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Molecular Biotechnology by : Bernard R. Glick

Download or read book Molecular Biotechnology written by Bernard R. Glick and published by . This book was released on 1998 with total page 724 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition explains the principles of recombinant DNA technology as well as other important techniques such as DNA sequencing, the polymerase chain reaction, and the production of monclonal antibodies.

Co-Founder, CEO, and Chairman of Genentech, Inc., 1976-1996

Author : Sally Smith Hughes
Publisher :
ISBN 13 : 9781296005733
Total Pages : 248 pages
Book Rating : 4.0/5 (57 download)

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Book Synopsis Co-Founder, CEO, and Chairman of Genentech, Inc., 1976-1996 by : Sally Smith Hughes

Download or read book Co-Founder, CEO, and Chairman of Genentech, Inc., 1976-1996 written by Sally Smith Hughes and published by . This book was released on 2015-02-14 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: This work has been selected by scholars as being culturally important, and is part of the knowledge base of civilization as we know it. This work was reproduced from the original artifact, and remains as true to the original work as possible. Therefore, you will see the original copyright references, library stamps (as most of these works have been housed in our most important libraries around the world), and other notations in the work. This work is in the public domain in the United States of America, and possibly other nations. Within the United States, you may freely copy and distribute this work, as no entity (individual or corporate) has a copyright on the body of the work.As a reproduction of a historical artifact, this work may contain missing or blurred pages, poor pictures, errant marks, etc. Scholars believe, and we concur, that this work is important enough to be preserved, reproduced, and made generally available to the public. We appreciate your support of the preservation process, and thank you for being an important part of keeping this knowledge alive and relevant.

Pharmaceutical Manufacturing Handbook

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
ISBN 13 : 0470259825
Total Pages : 857 pages
Book Rating : 4.4/5 (72 download)

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Book Synopsis Pharmaceutical Manufacturing Handbook by : Shayne Cox Gad

Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-04-04 with total page 857 pages. Available in PDF, EPUB and Kindle. Book excerpt: With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.