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Environmental Management System Iso 14001 2004

Author: Syed Imtiaz Haider
Publisher: CRC Press
ISBN: 9781439829400
Size: 34.74 MB
Format: PDF, ePub, Mobi
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Environmental Management System ISO 14001:2004 provides the information and practical know-how required to facilitate a smooth adoption and incorporation of the latest revisions and enhancements put forth by the International Organization for Standardization. This unique work shows how to adopt or transition to the documentation procedures required for an Environmental Management System (EMS) using the 14001:2004 series of standards. These globally accepted procedures help eliminate waste and improve efficiency, while providing the means to achieve both local and international compliance. This tool supplies step-by-step guidance on how to develop and implement an EMS that, with little effort, can be instantly applied to any process-related industry or organization interested in environmental compliance, whether it is regulated or not. A complete, single-source reference, written in simple and precise language, the book puts the answers to complex and thorny issues at your fingertips. It includes samples of policy statements, objectives, targets, and programs that can be amended or adopted without wasting time re-inventing the wheel. The CD-ROM includes customizable Standard Operating Procedures (SOPs) that can be downloaded, edited, printed, and easily tailored to incorporate changes and add organizational requirements. The SOPs exclusively refer to the documents specially required for compliance; however other formats are included to ensure that the soft copy can be easily used worldwide in a diverse range of industries and organizations. The book helps minimize documentation and avoid the nightmare faced by management representatives at the time of certification. An effective time saver when you are in the process of writing and organizing documentation for certification and further improvement purposes, this book and CD-ROM package helps you easily translate the revised ISO 14001:1996 and ISO 14001:2004 standard requirements into immediate action.

Cleaning Validation Manual

Author: Syed Imtiaz Haider
Publisher: CRC Press
ISBN: 9781439826614
Size: 31.43 MB
Format: PDF, ePub, Docs
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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-use training tools. Until now. Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries elucidates how to train the man power involved in development, manufacturing, auditing, and validation of bio pharmaceuticals on a pilot scale, leading to scale-up production. With over 20 easy-to-use template protocols for cleaning validation of extensively used equipments, this book provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. Drawing on the authors’ more than two decades of experience in the pharmaceutical and biotech industries, the text offers hands-on training based on current approaches and techniques. The book does not merely provide guidelines or thought processes, rather it gives ready-to-use formulas to develop Master Plan, SOPs, and validation protocols. It includes cleaning procedures for the most commonly used equipment in various manufacturing areas and their sampling points, using a pharmaceutical manufacturing site with both sterile and non-sterile operations as the case facility. It also provides the training guidelines on a CD-ROM to enable users to amend or adopt them as necessary. Grounded in practicality, the book’s applicability and accessibility set it apart. It can be used as a guide for implementing a cleaning validation program on site without the help of external consultants, making it a resource that will not be found collecting dust on a shelf, but rather, referred to again and again.

Quality Control Training Manual

Author: Syed Imtiaz Haider
Publisher: CRC Press
ISBN: 143985016X
Size: 56.76 MB
Format: PDF, ePub
View: 3194
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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.

Quality Operations Procedures For Pharmaceutical Api And Biotechnology

Author: Syed Imtiaz Haider
Publisher: CRC Press
ISBN: 143988692X
Size: 24.64 MB
Format: PDF, Mobi
View: 6474
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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.

Validation Standard Operating Procedures

Author: Syed Imtiaz Haider
Publisher: CRC Press
ISBN: 9781420009415
Size: 23.96 MB
Format: PDF, Mobi
View: 443
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Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluations, it features 64 new protocols on topics such as sterility assurance, media fill guidelines, and environmental control.

Biotechnology

Author: Syed Imtiaz Haider
Publisher: CRC Press
ISBN: 1420084496
Size: 70.13 MB
Format: PDF, ePub, Mobi
View: 4815
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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 Biotechnology Industry provides ready-to-implement training templates that save time and expense without cutting corners on critical elements. Attached CD-ROM: Why Reinvent the Wheel? This complete, single-source reference contains 28 complete biotechnology courses and a customizable CD-ROM with hands-on training tools. The book also provides time-saving information on how to orient employees involved in writing and executing batch manufacturing and in-process control documents. Key Benefits: Contains adaptable training text, test summaries and papers, test answers, and certificates of completion Streamlines the training process, maximizing efficiency Boosts the marketing edge over competitors This valuable training tool presents step-by-step guidance for optimizing research and development expenditures, avoiding marketing delays, gaining a competitive advantage, reducing product development failures, developing skilled manpower, and maintaining local and international regulatory compliance.

Sustainability Assessment

Author: Rupert Baumgartner
Publisher: Springer-Verlag
ISBN: 3322811328
Size: 12.37 MB
Format: PDF, ePub
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Rupert J. Baumgartner entwickelt ein Modell zur gleichrangigen Bewertung ökologischer und ökonomischer Aspekte von Produkten, Dienstleistungen und Technologien als Basis für unternehmensstrategische Entscheidungen. Mittels Fuzzy Logic werden situationsspezifisch eine ökologische Teilbewertung und eine ökonomische Teilbewertung unter nachhaltigen Gesichtspunkten zusammengeführt. Die Arbeit wurde mit dem Umweltforschungspreis 2003 des Industrieunternehmens Voestalpine AG ausgezeichnet.

Handbuch Internationale Beziehungen

Author: Frank Sauer
Publisher: Springer-Verlag
ISBN: 3531199188
Size: 79.19 MB
Format: PDF, ePub
View: 7503
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Das Handbuch Internationale Beziehungen ist die zweite, vollständig überarbeitete und erweiterte Auflage des Handbuchs der Internationalen Politik. Das neue Handbuch vermittelt einen umfassenden Überblick über den state of the art der politikwissenschaftlichen Teildisziplin Internationale Beziehungen in deutscher Sprache. Es präsentiert theoretische und methodische Grundlagen der Forschung in den Internationalen Beziehungen und stellt die wesentlichen Akteure und Problemfelder der internationalen Politik vor. Das Nachschlagewerk richtet sich sowohl an Wissenschaftlerinnen und Wissenschaftler als auch an Studierende und die interessierte Öffentlichkeit.