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Author : Daniel Farb, M.D.
Publisher : Universityofhealthcare
ISBN 13 : 9781594910265
Total Pages : 258 pages
Book Rating : 4.9/5 (12 download)
Download or read book GMP Training Package, Manual and CD written by Daniel Farb, M.D. and published by Universityofhealthcare. This book was released on 2003-12-01 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Anthony Luttrell
Publisher : Universityofhealthcare
ISBN 13 : 9781594910371
Total Pages : 61 pages
Book Rating : 4.9/5 (13 download)
Download or read book Pharmaceutical Quality Control Lab written by Anthony Luttrell and published by Universityofhealthcare. This book was released on 2004 with total page 61 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Quality Control Lab teaches you the history of regulations affecting quality control in pharmaceutical labs and their importance, and then goes into the specifics of dealing with out of standard and out of trend results in a pharmaceutical quality control lab. It contains an interactive flow chart, numerous step -by-step instructions, questions, an SOP model, and a case study. It is suitable for GMP training. Estimated time: 2-5 hours. 199 pages on CD. 61 pages in the manual include a handy printout of the FDA regulations part 210 and part 211. For convenience, the CD contains the text of some of the regulations. The manual accompanying the CD provides a summary of the major points of the CD in a handy format. You must have Internet Explorer 4.0 or higher running on your computer. Supported operating systems are Windows 95, 98, 98 SE, ME, 2000, or XP. The CD is licensed to play once on any Windows computer; the borrower may purchase the program after that. One library reference activation is included in the price.
Author : Syed Imtiaz Haider
Publisher : CRC Press
ISBN 13 : 143985016X
Total Pages : 484 pages
Book Rating : 4.4/5 (398 download)
Download or read book Quality Control Training Manual written by Syed Imtiaz Haider and published by CRC Press. This book was released on 2016-04-19 with total page 484 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences
Author : Daniel Farb
Publisher : Universityofhealthcare
ISBN 13 : 9781932634686
Total Pages : 61 pages
Book Rating : 4.6/5 (346 download)
Download or read book Pharmaceutical Quality Control Lab written by Daniel Farb and published by Universityofhealthcare. This book was released on 2003-12-01 with total page 61 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Quality Control Lab teaches you the history of regulations affecting quality control in pharmaceutical labs and their importance and the goes into the specifics of dealing with out of standard and out of trend in a pharmaceutical quality control lab.
Author : Daniel Farb
Publisher : Universityofhealthcare
ISBN 13 : 9781932634679
Total Pages : 86 pages
Book Rating : 4.6/5 (346 download)
Download or read book Pharmaceutical Computer Validation Introduction written by Daniel Farb and published by Universityofhealthcare. This book was released on 2003-12-01 with total page 86 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Computer Validation Introduction gives you a comprehensive introduction to computer systems validation as the computers come to life while the head of computer systems at a pharmaceutical company has to prepare for an FDA inspection. You will learn about regulations, the personnel responsible for computer validation, how to accomplish validation, and so on.
Author : Daniel Farb, M.D.
Publisher : Universityofhealthcare
ISBN 13 : 9781932634662
Total Pages : 249 pages
Book Rating : 4.6/5 (346 download)
Download or read book Agent Gxp Fda Part 11 written by Daniel Farb, M.D. and published by Universityofhealthcare. This book was released on 2003-12-01 with total page 249 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : James M. Miller
Publisher : Wiley-Interscience
ISBN 13 :
Total Pages : 520 pages
Book Rating : 4.3/5 (91 download)
Download or read book Analytical Chemistry in a GMP Environment written by James M. Miller and published by Wiley-Interscience. This book was released on 2000-05 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: How to hone your analytical skills and obtain high-quality data in the era of GMP requirements With increased regulatory pressures on the pharmaceutical industry, there is a growing need for capable analysts who can ensure appropriate scientific practices in laboratories and manufacturing sites worldwide. Based on Johnson & Johnson's acclaimed in-house training program, this practical guide provides guidance for laboratory analysts who must juggle the Food and Drug Administration's good manufacturing practices (GMP) rules with rapidly changing analytical technologies. Highly qualified industry experts walk readers step-by-step through the concepts, techniques, and tools necessary to perform analyses in an FDA-regulated environment, including clear instructions on all major analytical chemical methods-from spectroscopy to chromatography to dissolution. An ideal manual for formal training as well as an excellent self-study guide, Analytical Chemistry in a GMP Environment features: * The drug development process in the pharmaceutical industry * Uniform and consistent interpretation of GMP compliance issues * A review of the role of statistics and basic topics in analytical chemistry * An emphasis on high-performance liquid chromatographic (HPLC) methods * Chapters on detectors and quantitative analysis as well as data systems * Methods for ensuring that instruments meet standard operating procedures (SOP) requirements * Extensive appendixes for unifying terms, symbols, and procedural information
Author : Mark Clute
Publisher : CRC Press
ISBN 13 : 0849380294
Total Pages : 536 pages
Book Rating : 4.8/5 (493 download)
Download or read book Food Industry Quality Control Systems written by Mark Clute and published by CRC Press. This book was released on 2008-10-22 with total page 536 pages. Available in PDF, EPUB and Kindle. Book excerpt: After a sordid litany of recalls courtesy of the food industry, consumers are pointing the finger at companies that have failed to institute proper recall prevention techniques. While historical analysis shows no company is exempt from recall risk, most can be prevented with an efficient and verifiable quality control program.Authored by a 20-year
Author : GMP Institute
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (269 download)
Download or read book Count on Us for Quality written by GMP Institute and published by . This book was released on 1986 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Bruce Gordon
Publisher : University of Health Care
ISBN 13 : 9781594910968
Total Pages : 0 pages
Book Rating : 4.9/5 (19 download)
Download or read book GMP Training Package written by Bruce Gordon and published by University of Health Care. This book was released on 2004 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Deals with the FDA Regulations on Part 11, Electronic Records and Electronic Signatures, for Pharmaceutical, Medical Device, Food, and Cosmetics Manufacturing.
Author : Syed Imtiaz Haider
Publisher : CRC Press
ISBN 13 : 1439849943
Total Pages : 486 pages
Book Rating : 4.4/5 (398 download)
Download or read book Quality Control Training Manual written by Syed Imtiaz Haider and published by CRC Press. This book was released on 2011-02-16 with total page 486 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences to produce commercially viable biotech products and services in terms of quality, safety, and efficacy. This book and its accompanying CD-ROM comprise detailed text, summaries, test papers, and answers to test papers, providing an administrative solution for management. Provides the FDA, Health Canada, WHO, and EMEA guidelines directly applicable to pharmaceutical laboratory-related issues Offers generic formats and styles that can be customized to any organization and help management build quality into routine operations to comply with regulatory requirements Contains ready-to-use training courses that supply a good source of training material for experienced and inexperienced practitioners in the biotechnology/biopharmaceutical industries Includes a CD with downloadable training courses that can be adopted and directly customized to a particular organization Supplies ready-to-use test papers that allow end users to record all raw data up to the issuance of the attached certificate The biotechnology/bioscience industries are regulated worldwide to be in compliance with cGMP and GLP principles, with particular focus on safety issues. Each company must create a definite training matrix of its employees. The training procedures in this book enable end users to understand the principles and elements of manufacturing techniques and provide documentation language ranging from the generic to the specific. The training courses on the CD supply valuable tools for developing training matrices to achieve FDA, Health Canada, EMEA, MHRA UK, WHO, and GLP compliance.
Author : Carl Mottram
Publisher : Elsevier Health Sciences
ISBN 13 : 0323085059
Total Pages : 529 pages
Book Rating : 4.3/5 (23 download)
Download or read book Ruppel's Manual of Pulmonary Function Testing10 written by Carl Mottram and published by Elsevier Health Sciences. This book was released on 2013-01-01 with total page 529 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rev. ed. of: Manual of pulmonary function testing / Gregg L. Ruppel. 9th ed. c2009.
Author : Syed Imtiaz Haider
Publisher : CRC Press
ISBN 13 : 1439826617
Total Pages : 608 pages
Book Rating : 4.4/5 (398 download)
Download or read book Cleaning Validation Manual written by Syed Imtiaz Haider and published by CRC Press. This book was released on 2010-05-24 with total page 608 pages. Available in PDF, EPUB and Kindle. Book excerpt: During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-
Author : Syed Imtiaz Haider
Publisher : CRC Press
ISBN 13 : 1439886903
Total Pages : 586 pages
Book Rating : 4.4/5 (398 download)
Download or read book Quality Operations Procedures for Pharmaceutical, API, and Biotechnology written by Syed Imtiaz Haider and published by CRC Press. This book was released on 2012-06-06 with total page 586 pages. Available in PDF, EPUB and Kindle. Book excerpt: To stay in compliance with regulations, pharmaceutical, medical, and biotech companies must create qualtiy SOPs that build in the regulatory requirements into actions and describe personal flow, internal flow, flow of information, and processing steps. Quality Operations Procedures for Pharmaceutical, API, and Biotechnology and the accompanying CD-ROM take into account all major international regulations, such as FDA, EU GMP, cGMP, GLP, PDA technical monographs, PDA technical reports, PMA concepts, journals of PDA, GCP, and industry standard ISO 9000, to be in compliance with documentation guidelines. No other resource deals exclusively with the key elements of quality control and quality assurance procedures for pharmaceutical operations and provides hands-on templates to be tailored to achieve global regulatory compliance. The book provides instant answers about what to include in critical quality assurance and quality control SOPs and how to enhance productivity. The CD-ROM contains nineteen quality control and thirty-three quality assurance SOPs designed so that users can input them into their computers and use their Microsoft Word programs to edit and print these documents. The book ensures minimization of the number of documents, helping to reduce the nightmare-like aura that surrounds an FDA audit. The SOPs exclusively refer to the documents specially required for compliance; however, specific formats are not included to ensure that the electronic templates can be easily used by pharmaceutical, bulk pharmaceutical, medical device, and biotechnology industries. The combination of text and CD-ROM presents a ready-to-use resource on the quality systems of aseptic pharmaceutical non-aseptic production and to provide general information and guidelines. They comprise a tool that can be used to develop a set of quality SOPs in order to support the road map established for the on-time successful start-up of the facility operation in compliance with the GMP requirements.
Author : Syed Imtiaz Haider
Publisher : CRC Press
ISBN 13 : 1420084496
Total Pages : 868 pages
Book Rating : 4.4/5 (2 download)
Download or read book Biotechnology written by Syed Imtiaz Haider and published by CRC Press. This book was released on 2009-04-13 with total page 868 pages. Available in PDF, EPUB and Kindle. Book excerpt: All manufacturing companies face the daunting task of designing an employee training matrix that meets the gamut of national and international regulatory standards. Answering the call for a one-stop training resource that focuses exclusively on this multi-faceted, high-tech industry, Biotechnology: A Comprehensive Training Guide for the Biotechnolo
Author : Shayne Cox Gad
Publisher : John Wiley & Sons
ISBN 13 : 0470259809
Total Pages : 1384 pages
Book Rating : 4.4/5 (72 download)
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.
Author : Robert McDowall
Publisher : Royal Society of Chemistry
ISBN 13 : 1782624074
Total Pages : 778 pages
Book Rating : 4.7/5 (826 download)
Download or read book Validation of Chromatography Data Systems written by Robert McDowall and published by Royal Society of Chemistry. This book was released on 2016-11-23 with total page 778 pages. Available in PDF, EPUB and Kindle. Book excerpt: Guiding chromatographers working in regulated industries and helping them to validate their chromatography data systems to meet data integrity, business and regulatory needs. This book is a detailed look at the life cycle and documented evidence required to ensure a system is fit for purpose throughout the lifecycle. Initially providing the regulatory, data integrity and system life cycle requirements for computerised system validation, the book then develops into a guide on planning, specifying, managing risk, configuring and testing a chromatography data system before release. This is followed by operational aspects such as training, integration and IT support and finally retirement. All areas are discussed in detail with case studies and practical examples provided as appropriate. The book has been carefully written and is right up to date including recently released FDA data integrity guidance. It provides detailed guidance on good practice and expands on the first edition making it an invaluable addition to a chromatographer’s book shelf.
