Pharmaceutical Industry Documents
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Write It Down
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Author : Janet Gough
language : en
Publisher: CRC Press
Release Date : 2005-03-30
Write It Down written by Janet Gough and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-03-30 with Medical categories.
A well-understood tenet exists among the FDA and other regulatory bodies: if you didn't write it down, it didn't happen. And if it didn't happen, your company stands to lose time, money, and perhaps its competitive edge. Write it Down: Guidance for Preparing Effective and Compliant Documentation provides you with the tools you need to put effective documentation in place. The book has a three-pronged focus: to help writers understand the why of what they must write and the current industry standards for good documentation practices, to provide effective examples of a broad spectrum of documents, and to supply an in-depth explanation of grammar and punctuation conventions. Substantially expanded, the second edition focuses on the regulations, the need to document, and the range of documentation that must be in place to support therapeutic products from discovery through market. Readers will find useful examples of good writing, many provided by people in the industry. Letters and memos; short reports of varied topics, including equipment evaluation, vendor audit, and trip review; standard operating procedures, laboratory methods, and training materials; documentation for an IQ/OQ/PQ project; a journal article; and excerpts from a development report and a dossier are among the many examples. The book also gives a thorough explanation of grammar, punctuation, and usage, with a strong emphasis on the components of the language that pose difficulties for non-native writers of English. This book is a must for people working in or preparing to work in environments that produce drugs, medical devices, or biologics for sale in countries that have stringent regulatory requirements and where the business language is English. Firmly placing the writing task in context of the existing laws and guidances, the book offers valuable insights into managing systems and producing documentation that meets the requirements of the binding regulations.
Pharmaceutical Industry Documents
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Author : Chandrasekhar Panda
language : en
Publisher: Pencil
Release Date : 2021-04-20
Pharmaceutical Industry Documents written by Chandrasekhar Panda and has been published by Pencil this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-04-20 with Juvenile Nonfiction categories.
About the book: This PDF contains 90 numbers pharmaceutical Industry Quality Assurance Questions and Answers which will become useful to freshers as well as 1 to 3 years of experience candidate to gain knowledge. About the author: The author of Pharmaceutical Industry Documents is Chandrasekhar panda who is having more than 13 years of Experience in Pharmaceutical Quality Assurance department and he has worked in various Pharma companies like Cipla, USV & Aurobindo Pharma Limited. The author is also having a Pharmaceutical Blog named pharmaceuticalupdates.com and written various articles or topics regarding Pharmaceutical industry.
Pharmaceutical Industry Documents
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Author : Chandrasekhar Panda
language : en
Publisher:
Release Date : 2021-05-19
Pharmaceutical Industry Documents written by Chandrasekhar Panda and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-05-19 with Fiction categories.
This PDF contains 90 numbers pharmaceutical Industry Quality Assurance Questions and Answers which will become useful to freshers as well as 1 to 3 years of experience candidate to gain knowledge.
Targeted Regulatory Writing Techniques Clinical Documents For Drugs And Biologics
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Author : Linda Fossati Wood
language : en
Publisher: Springer Science & Business Media
Release Date : 2009-01-05
Targeted Regulatory Writing Techniques Clinical Documents For Drugs And Biologics written by Linda Fossati Wood and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-01-05 with Medical categories.
This book describes the authors’ standard or ‘best’ practices used in writing regul- ed clinical documents for the drug and biologics industry. The fundamental premise of this book is that the end (documents submitted to a health authority) is dep- dent on the beginning (the planning and strategy that go into organizing written documentation). Each regulatory document inherently exists within a constellation of related documents. This book attempts to show the relationships between and among these documents and suggests strategies for organizing and writing these documents to maximize ef?ciency while developing clear and concise text. At all times, and irrespective of applicable laws and guidelines, good communication skills and a sense of balance are essential to adequately, accurately, and clearly describe a product’s characteristics. At no time should the reader perceive these suggestions to be the only viable solution to writing regulatory documents nor should the reader expect that these suggestions guarantee product success. The audience for this book is the novice medical writer, or those who would like to explore or enhance regulatory-writing skills. We assume the reader will have a basic understanding of written communication, but little experience in applying this skill to the task of regulatory writing. Extensive knowledge of science, clinical me- cine, mathematics, or regulatory affairs law is not required to use the best practices described in this book.
Modern Pharmaceutical Industry
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Author : Thomas Jacobsen
language : en
Publisher: Jones & Bartlett Learning
Release Date : 2010-10-25
Modern Pharmaceutical Industry written by Thomas Jacobsen and has been published by Jones & Bartlett Learning this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-10-25 with Business & Economics categories.
With its expansion into the global marketplace, the pharmaceutical industry of today is uniquely positioned to improve the global health standards of society by saving lives and improving the quality of lives around the world. Modern Pharmaceutical Industry: A Primer comprehensively explains the broad range of divisions in this complex industry. Experts actively involved in each division discuss their own contribution to a pharmaceutical company's work and success. Divisions include regulatory affairs, research and development, intellectual property, pricing, marketing, generics, OTC, and more
Regulatory Affairs In The Pharmaceutical Industry
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Author : Javed Ali
language : en
Publisher: Academic Press
Release Date : 2021-11-14
Regulatory Affairs In The Pharmaceutical Industry written by Javed Ali and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-11-14 with Medical categories.
Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance
Knowledge Management In The Pharmaceutical Industry
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Author : Elisabeth Goodman
language : en
Publisher: Routledge
Release Date : 2016-04-22
Knowledge Management In The Pharmaceutical Industry written by Elisabeth Goodman and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-22 with Business & Economics categories.
The Pharmaceutical Industry has been undergoing a major transformation since the heady days of 'big pharma' in the 1970s and 80s. Patent expiry, the rise of generics, and the decline of the blockbuster drug have all changed the landscape over the last 10-15 years. It's an environment where products can take 10 years or more to come to market, billions are spent on research and development, jobs are being shed in the western pharma homelands and regulators and the public are more demanding than ever. So what part is Knowledge Management playing and going to play in this vital international industry? Knowledge Management (KM) has many facets from providing comprehensive knowledge bases for workers, through the sharing of advice and problem solving, to providing an environment for innovation and change. This book, focusing on research and development, and manufacturing-based companies, explores how a range of techniques and approaches have been applied in the unique environment of the Pharmaceutical Industry, and examine how it can help the industry in the 21st century. Whilst the book is centered on the Pharmaceutical Industry, its objective will be to discuss and demonstrate how Knowledge Management can be applied in a variety of environments, and with a range of cultural issues. KM practitioners, and potential practitioners, both within and outside the Pharmaceutical Industry, will be able to gain valuable guidance and advice from both the examples of good practice and the lessons learned by the authors and contributors.
Quality Assurance Of Pharmaceuticals
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2004
Quality Assurance Of Pharmaceuticals written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004 with Business & Economics categories.
Over the years, the World Health Organization's Expert Committee on Specifications for Pharmaceutical Preparations, originally created to prepare The International Pharmacopoeia, has made numerous recommendations relevant to quality assurance and control for national regulatory and control systems and the implementation of international standards, but for the most part they have only been available in the annexes to various technical reports. In this second of two volumes, those annexes providing guidelines related to good manufacturing practices and to inspection of manufacturers and drug distribution channels have been gathered and revised. Annotation : 2004 Book News, Inc., Portland, OR (booknews.com).
Good Manufacturing Practices For Pharmaceuticals
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Author : Joseph D. Nally
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Good Manufacturing Practices For Pharmaceuticals written by Joseph D. Nally and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.
Validation Standard Operating Procedures
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Author : Syed Imtiaz Haider
language : en
Publisher: CRC Press
Release Date : 2001-12-27
Validation Standard Operating Procedures written by Syed Imtiaz Haider and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001-12-27 with Business & Economics categories.
One of the most common reasons so many new drug, medical device, or equipment applications are rejected each year by the FDA is the failure to properly develop and document plans and procedures. This is required of both U.S. and foreign companies wishing to market their products in the United States. The lack of well defined validation standard operating procedures may result in adverse FDA findings, recalls, and heavy financial losses. Key FDA guidelines on good manufacturing practice (GMP), good laboratory practice (GLP), and validation do not describe exactly how to develop a master validation plan, how to achieve compliance, or the standard operating procedures and documentation required. This text provides the required validation standard operating procedures and documentation necessary for achieving compliance in the pharmaceutical industry. The text and CD are designed to minimize workload and optimize time, money, and resources. A comprehensive when-and-how-to-do-it guide, Validation Standard Operating Procedures provides the needed administrative solutions and guidance for achieving compliance with FDA requirements, and for obtaining authorization to market products in the United States. The CD-ROM contains 74 template validation standard operating procedures that can be tailored to meet the regulatory compliance requirements of any pharmaceutical, diagnostic, medical device, medical equipment, and biotech product. You can edit, print, and customize these procedures to fit your needs. The book and CD work together to minimize the number of documents used and to ensure their accuracy. All critical elements and requirements of validation are covered, so you can easily implement them and avoid the stress that usually accompanies an FDA audit. Features Provides all the information that managers need to establish functions, acceptance criteria, and validation procedures in compliance with FDA guidelines Includes step-by-step directions for translating GMP requirements into action, based on your company's Master Validation Plan and execution protocols Describes how to establish test functions and prevent defects in order to produce products that are fit for use Serves as an ideal companion to Haider's Pharmaceutical Master Validation Plan