Validating Regulatory Analysis


Book Description










Models in Environmental Regulatory Decision Making


Book Description

Many regulations issued by the U.S. Environmental Protection Agency (EPA) are based on the results of computer models. Models help EPA explain environmental phenomena in settings where direct observations are limited or unavailable, and anticipate the effects of agency policies on the environment, human health and the economy. Given the critical role played by models, the EPA asked the National Research Council to assess scientific issues related to the agency's selection and use of models in its decisions. The book recommends a series of guidelines and principles for improving agency models and decision-making processes. The centerpiece of the book's recommended vision is a life-cycle approach to model evaluation which includes peer review, corroboration of results, and other activities. This will enhance the agency's ability to respond to requirements from a 2001 law on information quality and improve policy development and implementation.







Whole Slide Imaging


Book Description

This book provides up-to-date and practical knowledge in all aspects of whole slide imaging (WSI) by experts in the field. This includes a historical perspective on the evolution of this technology, technical aspects of making a great whole slide image, the various applications of whole slide imaging and future applications using WSI for computer-aided diagnosis The goal is to provide practical knowledge and address knowledge gaps in this emerging field. This book is unique because it addresses an emerging area in pathology for which currently there is only limited information about the practical aspects of deploying this technology. For example, there are no established selection criteria for choosing new scanners and a knowledge base with the key information. The authors of the various chapters have years of real-world experience in selecting and implementing WSI solutions in various aspects of pathology practice. This text also discusses practical tips and pearls to address the selection of a WSI vendor, technology details, implementing this technology and provide an overview of its everyday uses in all areas of pathology. Chapters include important information on how to integrate digital slides with laboratory information system and how to streamline the “digital workflow” with the intent of saving time, saving money, reducing errors, improving efficiency and accuracy, and ultimately benefiting patient outcomes. Whole Slide Imaging: Current Applications and Future Directions is designed to present a comprehensive and state-of the-art approach to WSI within the broad area of digital pathology. It aims to give the readers a look at WSI with a deeper lens and also envision the future of pathology imaging as it pertains to WSI and associated digital innovations.




Fish and Fishery Products


Book Description

This guidance will assist processors of fish and fishery products in the development of their Hazard Analysis Critical Control Point (HACCP) plans. Processors of fish and fishery products will find info. that will help them identify hazards that are associated with their products, and help them formulate control strategies. It will help consumers understand commercial seafood safety in terms of hazards and their controls. It does not specifically address safe handling practices by consumers or by retail estab., although the concepts contained in this guidance are applicable to both. This guidance will serve as a tool to be used by fed. and state regulatory officials in the evaluation of HACCP plans for fish and fishery products. Illustrations. This is a print on demand report.







Analytical Method Validation and Instrument Performance Verification


Book Description

Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.




Government Auditing Standards - 2018 Revision


Book Description

Audits provide essential accountability and transparency over government programs. Given the current challenges facing governments and their programs, the oversight provided through auditing is more critical than ever. Government auditing provides the objective analysis and information needed to make the decisions necessary to help create a better future. The professional standards presented in this 2018 revision of Government Auditing Standards (known as the Yellow Book) provide a framework for performing high-quality audit work with competence, integrity, objectivity, and independence to provide accountability and to help improve government operations and services. These standards, commonly referred to as generally accepted government auditing standards (GAGAS), provide the foundation for government auditors to lead by example in the areas of independence, transparency, accountability, and quality through the audit process. This revision contains major changes from, and supersedes, the 2011 revision.