Download or read book PRODUCT RISK REDUCTION IN THE CHEMICAL INDUSTRY A HANDBOOK FOR MANAGING PRODUCT AND REGULATORY IMPACT written by LA. MILLER and published by . This book was released on 1985 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Chemical Risk Assessment written by Peter Fisk and published by John Wiley & Sons. This book was released on 2013-10-28 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is an essential guide and support to understanding of the science and policy, procedure and practice that underpins the REACH risk assessments required for the use and placing on the market of chemicals in the European Union. A clear understanding of information provision and how this affects the assessment of chemical safety is fundamentally important to the success of policy on chemicals and ultimately to the sustainability of the chemicals industry. Within the book, the scientific processes that underpin the policy are explained in a practical way. Importantly, it includes coverage of techniques to help solve the problems of using potentially risky and hazardous chemicals through the use of less hazardous alternatives and ‘green chemistry’, and also the analysis of the risks of the use of the most hazardous substances against the social and economic benefits of use. Chemical Risk Assessment: A Manual for REACH covers the following main themes: i) Assessment of chemical risk; ii) Risk management; iii) Hazard reduction, substitution and green chemistry; iv) Risk versus benefit – socio-economic analysis. The book acts as a practical guide and overview to chemicals risk assessment and risk management (in the EU context), as well as a support text for planning for the challenges of the future, which will see ever-increasing pressure to withdraw hazardous substances from the EU (and global) market, balanced against opportunities for innovation in the development of less hazardous chemicals.
Download or read book Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing written by Hamid Mollah and published by John Wiley & Sons. This book was released on 2013-03-18 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applications Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing Bibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.
Download or read book Within Reach written by David Walters and published by Routledge. This book was released on 2017-03-02 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examines regulatory and other strategies for improving chemical risk management in small enterprises in the European Union. This book considers what supports are necessary to secure the implementation of these strategies and is particularly concerned with the role of chemical product supply as envisaged by REACH.
Download or read book Risk Assessment and Risk Management for the Chemical Process Industry written by Stone & Webster Engineering Corporation and published by John Wiley & Sons. This book was released on 1991-09-03 with total page 398 pages. Available in PDF, EPUB and Kindle. Book excerpt: The tragic incident at Bhopal, India made it clear that safetyreviews for identification and control of accidents involving toxicchemicals must be more systematic. This guide shows how tointegrate hazard identification, risk assessment, consequenceanalysis, and risk mitigation into a formalized program forhandling hazardous chemicals. Most of the 21 contributors aresenior staff members at Stone & Webster EngineeringCorporation. They discuss how to perform and supervise safetystudies for chemical, petrochemical, petroleum refining, and otherfacilities. They discuss all aspects of detection, prevention, andmitigation of risks associated with processing, handling, andproduction of hazardous chemicals. Special attention is given tohazard identification and hazard assessment techniques ranging fromsimple screening checklists to highly structured Hazard andOperability (HAZOP) analysis. You're shown how to calculatepotential consequences of identified hazards, quantify thelikelihood of these events, and combine equipment failure rate dataand human reliability analysis with hazard assessment. You'll alsobenefit from the book's rundowns of how to * apply expert systems and artificial intelligence in riskmanagement * instill safety-oriented operating and maintenanceprocedures * train operators and emergency response personnel * conduct internal and external safety audits * perform chemical dispersion, explosion, and fire analyses * assess health effects from chemical releases * use insurance vehicles to deal with residual risk. Risk Assessment and Risk Management for the Chemical ProcessIndustry is an essential source on minimizing the dangers of toxicincidents and accidents. It is essential reading for safetyengineers, regulatory managers, environmental engineers, and otherprofessionals responsible for safety in chemical plants.
Download or read book Product Stewardship written by Kathleen Sellers and published by CRC Press. This book was released on 2015-05-13 with total page 125 pages. Available in PDF, EPUB and Kindle. Book excerpt: Consider the Consequences of Bringing a Chemical to MarketProduct Stewardship: Life Cycle Analysis and the Environment explores the regulatory and scientific aspects of the life-cycle consequences of bringing a chemical to market. Using case studies to bring critical points to life, this multidisciplinary text explores the factors that influence ou
Download or read book Risk Management of Chemicals written by M. L. Richardson and published by Elsevier. This book was released on 2014-03-14 with total page 415 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume of proceedings reviews the status of risks entailed in the manufacture, handling, use and disposal of the chemicals on which we all depend and suggests further action for the protection of both the workplace and the natural environment.
Download or read book Quality Risk Management in the FDA Regulated Industry written by Jose (Pepe) Rodriguez-Perez and published by Quality Press. This book was released on 2024-04-18 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: For quality professionals and manufacturers in the food safety and medical device industries, risk management is essential to ensuring organizations meet FDA regulations and requirements. Without these recognized standards, the lives of patients and consumers are placed in jeopardy. In this third edition of Quality Risk Management in the FDA-Regulated Industry, Jose Rodriguez-Perez provides an updated view of the risk management field as it applies to FDA-regulated products using risk-based thinking.
Download or read book Quality Risk Management in the FDA Regulated Industry written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2017-02-21 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first edition (2012), the emphasis on risk-based processes has growth exponentially across all sectors, and risk management is now considered as significant as quality management. ISO 9001 was revised and now requires that top management promote the use of risk-based thinking. ISO 13485:2016, which specifies the requirements for a quality management system specific to the medical devices industry, also now shows a greater emphasis on risk management and risk-based decision making. In addition, the FDA Food Safety Modernization Act (FSMA) is the most important reform of U.S. food safety laws in more than 70 years. This indispensable book presents a systematic and comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practice or good laboratory practice. All chapters have been updated and revised, and a new chapter has been added to discuss some of the most common pitfalls and misunderstandings regarding risk management, specifically those related to the use of FMEA as the only element of risk management programs. One of the appendices includes 12 case studies, and the companion CD-ROM contains dozens of U.S. FDA and European guidance documents as well as international harmonization documents (ICH and GHTF-IMDRF) related to risk management activities, as well as a 30-question exam (with answers) on the material discussed in the book.
Download or read book Global Risk Based Management of Chemical Additives I written by Bernd Bilitewski and published by Springer Science & Business Media. This book was released on 2012-01-06 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: Chemical additives are used to enhance the properties of many industrial products. Since their release into the environment is a potential risk for man and nature, their fate and behavior were investigated in the framework of the European Union-funded project RISKCYCLE. The results are presented in two volumes, Global Risk-Based Management of Chemical Additives I: Production, Usage and Environmental Occurrence and Global Risk-Based Management of Chemical Additives II: Risk-Based Assessment and Management Strategies. This book is the first of the two volumes and contains two main parts. The chapters of the first part provide a thorough review of the chemical additives used in the textile, plastics, lubricants, paper, leather and electronics industries, and describe the effect of each additive on the properties of the product. In the second part international case studies on the global trade of these chemicals and their impact on human health and the environment are presented. This volume is an invaluable source of information for scientists and governmental agencies dealing with the risk assessment of chemicals on a global scale.
Download or read book Chemicals in the Environment written by R M Harrison and published by Royal Society of Chemistry. This book was released on 2007-10-31 with total page 175 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rising concern in recent years over the possible adverse environmental consequences of the use of chemicals has led to a steady increase in national activity towards greater regulation, as well as voluntary agreements with manufacturers for risk management of certain products. This book begins by reviewing the current framework of legislation for the regulation of chemicals in the UK and then reports expert views on both the current situation and possible future developments. Subsequent chapters consider some of the scientific and technical issues, including the evaluation of the risks which chemicals can pose to human life and the environment, and the problems relating to evaluating the risks associated with metals in the environment. Finally, the predictive methods used to model the behaviour of organic chemicals within the environment are described. Highly topical, and with authoritative contributions from international experts, this book covers both the scientific underpinning and the legislative and practical issues of this emotive subject. The detailed coverage of a topic that affects many sectors of industry and society will make it popular with a wide audience of individuals from government organisations, industry or academic research, particularly those in environmental chemistry sectors.
Download or read book Handbook of Chemical Regulations written by Martha J. Boss and published by CRC Press. This book was released on 2015-08-08 with total page 586 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first book of its kind, Handbook of Chemical Regulations: Benchmarking, Implementation, and Engineering Concepts introduces the concept of global harmonization and interlinks between regulations and examines the reasons behind major requirements for chemical manufacture, article production, and distribution, importation, and usage. A compendium
Download or read book Guidelines for Chemical Transportation Safety Security and Risk Management written by CCPS (Center for Chemical Process Safety) and published by John Wiley & Sons. This book was released on 2010-08-13 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: This CCPS Guideline book outlines current transportation risk analysis software programs and demonstrates several available risk assessment programs for land transport by rail, truck, and pipeline for consequences that may affect the public or the environment. Provides introductory transport risk considerations for process engineers Gives guidance on route selection, equipment factors and materials Describes transportation security risk issues and industry practices to mitigate them Includes loading and unloading checklists for several transport modes Develops specific operating procedures and checklists to reduce human error Discusses considerations for transportation security, including threat and vulnerability assessments and potential countermeasures Summarizes key transportation security regulations, guidelines and industry initiatives. Note: CD-ROM/DVD and other supplementary materials are not included as part of eBook file.
Download or read book Handbook of Innovation Policy Impact written by Jakob Edler and published by Edward Elgar Publishing. This book was released on 2016-07-27 with total page 604 pages. Available in PDF, EPUB and Kindle. Book excerpt: Innovation underpins competitiveness, is crucial to addressing societal challenges, and its support has become a major public policy goal. But what really works in innovation policy, and why? This Handbook, compiled by leading experts in the field, is the first comprehensive guide to understanding the logic and effects of innovation polices. The Handbook develops a conceptualisation and typology of innovation policies, presents meta-evaluations for 16 key innovation policy instruments and analyses evidence on policy-mix. For each policy instrument, underlying rationales and examples are presented, along with a critical analysis of the available impact evidence. Providing access to primary sources of impact analysis, the book offers an insightful assessment of innovation policy practice and its evaluation.
Download or read book Risk Assessment of Chemicals An Introduction written by C.J. van Leeuwen and published by Springer Science & Business Media. This book was released on 2007-09-18 with total page 706 pages. Available in PDF, EPUB and Kindle. Book excerpt: At last – a second edition of this hugely important text that reflects the progress and experience gained in the last decade and aims at providing background and training material for a new generation of risk assessors. The authors offer an introduction to risk assessment of chemicals as well as basic background information on sources, emissions, distribution and fate processes for the estimation of exposure of plant and animal species in the environment and humans exposed via the environment, consumer products, and at the workplace. The coverage describes the basic principles and methods of risk assessment within their legislative frameworks (EU, USA, Japan and Canada).
Download or read book Global Chemical Control Handbook written by Lynn L. Bergeson and published by American Bar Association. This book was released on 2014 with total page 434 pages. Available in PDF, EPUB and Kindle. Book excerpt: International governments are increasingly aware of the need for improved chemical management standards. Global Chemical Control Handbook provides an invaluable resource for keeping abreast of these developments in key U.S. and international chemical regulatory programs. The editor and authors provide a broad overview of critical international chemical management programs, describing the country s laws and regulatory implementation while offering useful insights on the transactional impact and enforcement opportunities that the program presents."
Download or read book The Combination Products Handbook written by Susan Neadle and published by CRC Press. This book was released on 2023-05-16 with total page 439 pages. Available in PDF, EPUB and Kindle. Book excerpt: Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.
