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The 2026 edition provides comprehensive explanations of the latest regulations, fully compliant with domestic CSV guidelines, covering PIC/S, FDA, EU GMP, CSA, and Annex 11/22 (AI). It is aimed at professionals involved in Computerized System Validation (CSV), quality assurance, quality control, regulatory affairs, IT system implementation, and compliance.
This book provides an overview of the increasing awareness of the circular economy, the trends in ISO standards, and the regulatory landscape surrounding environmental laws in Europe and other countries. It also discusses case studies of corporate and industry responses to these regulations, along with a section addressing common questions and new concepts related to environmental compliance.
This comprehensive technical book provides an overview of the PFAS issue through four axes: regulations, industry, technology, and analysis. It addresses the increasing regulatory scrutiny and societal interest in PFAS, organizing information on definitions, regulations, industrial impacts, separation and recovery, decomposition, and analysis. The introduction covers the classification of PFAS and the history of regulations, along with advanced decomposition and resource recovery technologies. The first chapter compares regulatory trends in the U.S., EU, and Japan, discussing the impacts on various industries such as semiconductors and packaging, as well as the development of alternative materials. Chapters 2 and 3 encompass the latest technologies including MOFs, ion exchange resins, ionic liquids, LFP methods, TERRAST, AOS, plasma, VUV light, visible light nanocrystals, and flow electrodes, along with insights from practical tests and field implementations. Chapter 4 presents the limitations of LC-MS/MS and the direction of analytical technologies, including thermal decomposition GC/MS.
