Download or read book Regulatory Compliance Fundamentals written by M.L. Humphrey and published by M.L. Humphrey. This book was released on 2020-01-02 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt: We live in a regulated world. And for someone whose role is in regulatory compliance or regulatory enforcement knowledge is often gained on an ad hoc basis through trial and error, via on the job training, or through conversations with others in a similar role. In Regulatory Compliance Fundamentals M.L. Humphrey has taken twenty years of experience as a regulator and a consultant in the financial services industry and boiled it down to the basic fundamental principles every individual in regulatory compliance should know, and presented that information in a straight-forward, easy to understand manner. If your role is in regulatory compliance, no matter how long you've been at this, this book is for you. keywords: regulatory compliance, financial services regulation, AML, OFAC, broker-dealer, how to comply with regulatory requirements, compliance program, reputational risk, business ethics

Download or read book Research Regulatory Compliance written by Mark A. Suckow and published by Academic Press. This book was released on 2015-06-14 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research Regulatory Compliance offers the latest information on regulations and compliance in the laboratory. With the increasing complexity of regulations and need for institutional infrastructure to deal with compliance of animal use issues, as well as a requirement surrounding human subjects, this publication provides reputable guidance and information. The book is extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and is also a great asset for faculty or new researchers coming in to the laboratory environment. It will help prepare users for the deluge of regulatory and compliance issues they will face while conducting their scientific programs. The book is edited and authored by known leaders in the field of compliance and regulations, and contains extensive research on the topics. It represents the new standard for information in every laboratory. Provides a “one-stop" , go-to resource for the many regulatory and compliance issues that affect laboratory study and research models Extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and also a great asset for faculty or new researchers coming in to the laboratory environment Focuses on United States regulations, covering both animal models and human subjects Written and edited by known leaders in the field of regulatory compliance who bring many years of collective experience to the book

Download or read book The IT Regulatory and Standards Compliance Handbook written by Craig S. Wright and published by Elsevier. This book was released on 2008-07-25 with total page 758 pages. Available in PDF, EPUB and Kindle. Book excerpt: The IT Regulatory and Standards Compliance Handbook provides comprehensive methodology, enabling the staff charged with an IT security audit to create a sound framework, allowing them to meet the challenges of compliance in a way that aligns with both business and technical needs. This "roadmap" provides a way of interpreting complex, often confusing, compliance requirements within the larger scope of an organization's overall needs. The ulitmate guide to making an effective security policy and controls that enable monitoring and testing against them The most comprehensive IT compliance template available, giving detailed information on testing all your IT security, policy and governance requirements A guide to meeting the minimum standard, whether you are planning to meet ISO 27001, PCI-DSS, HIPPA, FISCAM, COBIT or any other IT compliance requirement Both technical staff responsible for securing and auditing information systems and auditors who desire to demonstrate their technical expertise will gain the knowledge, skills and abilities to apply basic risk analysis techniques and to conduct a technical audit of essential information systems from this book This technically based, practical guide to information systems audit and assessment will show how the process can be used to meet myriad compliance issues

Download or read book Web Accessibility written by Richard Rutter and published by Apress. This book was released on 2007-03-19 with total page 686 pages. Available in PDF, EPUB and Kindle. Book excerpt: Web accessibility not just morally sound – there are legal obligations as well Very large potential audience, consisting of web developers and business managers Very little competition to this book

Download or read book OECD Regulatory Compliance Cost Assessment Guidance written by OECD and published by OECD Publishing. This book was released on 2014-04-28 with total page 78 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guidance document provides a practical, technical and user-friendly guidance on measuring and reducing compliance costs of regulation in OECD countries.

Download or read book The Challenge of CMC Regulatory Compliance for Biopharmaceuticals written by John Geigert and published by Springer. This book was released on 2019-05-08 with total page 426 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.

Download or read book Maintenance Management and Regulatory Compliance Strategies written by Terry Wireman and published by Industrial Press Inc.. This book was released on 2003 with total page 362 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory agencies and their requirements.

Download or read book Explaining Compliance written by Christine Parker and published by Edward Elgar Publishing. This book was released on 2011 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: 'Taking a broad view of regulation, and covering a wide range of issues and industries, this collection is the most innovative effort to date to understand the responses of business firms to regulation. The book brings together an impressive group of scholars who analyze the concept of compliance and offer theoretically informed studies of its assumed links to regulation. A must read for both academics and practitioners, this ground-breaking collection firmly establishes a scholarly field of compliance studies.' Ronen Shamir, Tel Aviv University, Israel 'Business responses to regulation is a key area of social science research. Parker and Nielsen's collection brings together an excellent group of scholars with innovative, and I believe highly influential contributions that problematize the relations between regulation and compliance. The collection is a highly welcome addition to our field, that will redefine the research agenda on compliance. A significant achievement that will help to improve policy making and frame the scholarly research agenda for the years to come.' David Levi-Faur, The Hebrew University of Jerusalem, Israel and the Free University of Berlin, Germany 'A timely and important set of analyses on how and why businesses respond to regulation in the way that they do from some of the leading authors in the field, covering business responses to both state and non-state regulatory systems.' Julia Black, London School of Economics, UK Explaining Compliance consists of sixteen specially commissioned chapters by the world's leading empirical researchers, examining whether and how businesses comply with regulation that is designed to affect positive behaviour changes. Each chapter consists of reflective summaries on business compliance with different state or voluntary regulation, and the theoretical lessons to be drawn from it. As a whole, the book develops understanding and explanations of how, why and in what circumstances, firms come to comply with regulation, and when they do not. It also uncovers the complexity, ambiguity and transformation of regulation as it is interpreted, implemented and negotiated by firms, their stakeholders and internal constituencies in everyday business life. This unique and detailed resource will appeal to academics, graduate students and senior undergraduates in law, political science, sociology, criminology, economics, and psychology, as well as business and interdisciplinary areas such as law and society, and law and economics. Anyone researching business regulation, corporate social responsibility, regulation and compliance, enforcement and compliance, and public administration, will also find this book beneficial.

Download or read book Motor Carrier Safety written by Erik Scott Dunlap and published by CRC Press. This book was released on 2020-07-26 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt: The need to understand and follow applicable government regulations is critical to providing safety for everyone affected by the transportation industry. Motor Carrier Safety simplifies the many complexities of legal compliance for the transportation of goods by highway. It provides you with the tools and focus required to achieve full regulatory compliance. The author examines current regulations to determine what issues and requirements pertain to such issues as hazardous materials, drugs and alcohol, employee safety and health. Bulleted lists present the regulations in a clear, easy-to-use format. You will understand the issues and be able to determine the specific regulations that affect your place of business. In addition to regulations and standards, this book covers points of training, record keeping, and suggestions for annual audits. Case studies relating to various regulations help you realize how either violating or complying will impact your business. These features combine to make Motor Carrier Safety the perfect vehicle for launching your in-house training program. The laws governing the transportation of goods by truck vary from agency to agency. Motor Carrier Safety makes clear the regulations and provides the you with a practical source for complying with them. This book helps you to understand your regulatory exposure for non-compliance and guides you through the steps to becoming compliant.

Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Download or read book Guide to Supply Chain Compliance Laws and Regulations written by Travis James Miller and published by . This book was released on 2021 with total page 105 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book The Cambridge Handbook of Compliance written by Benjamin van Rooij and published by Cambridge University Press. This book was released on 2021-05-20 with total page 1559 pages. Available in PDF, EPUB and Kindle. Book excerpt: Compliance has become key to our contemporary markets, societies, and modes of governance across a variety of public and private domains. While this has stimulated a rich body of empirical and practical expertise on compliance, thus far, there has been no comprehensive understanding of what compliance is or how it influences various fields and sectors. The academic knowledge of compliance has remained siloed along different disciplinary domains, regulatory and legal spheres, and mechanisms and interventions. This handbook bridges these divides to provide the first one-stop overview of what compliance is, how we can best study it, and the core mechanisms that shape it. Written by leading experts, chapters offer perspectives from across law, regulatory studies, management science, criminology, economics, sociology, and psychology. This volume is the definitive and comprehensive account of compliance.

Download or read book The Regulatory Compliance Matrix Regulation of Financial Services Information and Communication Technology and Generally Related Matters written by Guido Reinke and published by Gold Rush Publishing. This book was released on 2015-07-31 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: This exceptional guidebook is ideal for industry professionals, regulators and scholars in the domain of regulatory governance. The Regulatory Compliance Matrix with more than 2500 entries brings clarity to a domain which is widely considered to be complex, unstructured, and in constant flux. It is a compendious guide to the laws, regulations, standards, and recommendations applicable to compliance programmes. What practitioners find in this book will empower them to save money, man-hours, and consultancy interventions. Inside, the reader will find the following key resources: Regulatory Compliance Matrix: a synopsis of the principal domains of applicable regulation, setting forth legal norms, ancillary standards and guidelines. This Matrix covers the laws and regulations specific to financial services (Part I) and information and communications technology (Part II) at the global and European as well at the UK national and sub-national level. Part III of the Matrix covers generally applicable regulatory domains like corporate governance, consumer protection and employment law, information security, data protection and electronic commerce. Regulatory authorities: a comprehensive listing with descriptions of authorities who define the regulatory agenda. Weblinks are provided for each authority, which enables the reader to access the latest regulatory developments and updates. Overview of the conduct of effective compliance programmes: a pragmatic approach to the entire process, from scoping and prioritisation, conducting risk assessments, defining control activities and reporting requirements; to undertaking effectiveness reviews, documenting findings and making recommendations; to assessing compliance maturity and creating action plans. Non-compliance costs checklist: a detailed list of financial, operational, personal, and regulatory risks. This will assist readers with risk assessment and prioritisation of compliance domains."

Download or read book Medical Device Quality Assurance and Regulatory Compliance written by Richard C. Fries and published by CRC Press. This book was released on 1998-08-11 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."

Download or read book Corporate Legal Compliance Handbook 3rd Edition written by Banks and Banks and published by Wolters Kluwer. This book was released on 2020-06-19 with total page 1976 pages. Available in PDF, EPUB and Kindle. Book excerpt: Corporate Legal Compliance Handbook, Third Edition, provides the knowledge necessary to implement or enhance a compliance program in a specific company, or in a client's company. The book focuses not only on doing what is legal or what is right--the two are both important but not always the same--but also on how to make a compliance program actually work. The book is organized in a sequence that follows how to approach a compliance program. It gives the compliance officer, consultant, or attorney a good grounding in the basics of compliance law. This includes such things as the rules about corporate and individual liability, an understanding of the basics of the key laws that impact companies, and the workings of the U.S. Sentencing Guidelines. Successful programs also require an understanding of educational techniques, good communication skills, and the use of computer tools. The effective compliance program also takes into account how to deliver messages using a variety of media to reach employees in different locations, of different ages or education, who speak different languages. Note: Online subscriptions are for three-month periods.

Download or read book Environmental Compliance Made Easy written by Andre R. Cooper and published by Government Institutes. This book was released on 2003-08-01 with total page 446 pages. Available in PDF, EPUB and Kindle. Book excerpt: The newly revised and thoroughly updated Environmental Compliance Made Easy handbook from Government Institutes' popular 'Made Easy' series reorganizes thousands of pages worth of federal environmental regulatory programs into one easy-to-use compliance resource, organized by program. Intended as both a beginner's guide and a veteran's reference, this edition provides readers with a concise summary of the major environmental programs and introduces readers to the laws and regulations programs, key requirements, responsibilities of regulated parties, and compliance and auditing processes of each. In addition to covering air quality management, hazardous materials management, impact assessments, and underground storage tank management, this new edition now also covers homeland security and emergency response, compliance audits, information technology initiatives and innovation, pesticide management, property transfer and due diligence, solid waste and toxic substance management, and training. Readers will emerge with a fundamental understanding of which environmental management programs they should consider and how to implement them when developing proactive, successful, and reliable regulatory compliance programs. Key compliance sections include applicable methods, strategies for reviewing compliance status and implementing environmental programs, and checklists based on actual agency protocols. Readers can use the checklists to complete portions of their company's overall environmental compliance plan.

Download or read book Investment Adviser s Legal and Compliance Guide written by Terrance J. O'Malley and published by Wolters Kluwer. This book was released on 2013-01-01 with total page 1060 pages. Available in PDF, EPUB and Kindle. Book excerpt: Investment Adviser's Legal and Compliance Guide, Second Edition is an invaluable guide written to assist attorneys and investment advisers in both drafting their compliance policies and procedures and reviewing them annually. In addition, the book serves as a practical tool for experienced attorneys and compliance officers for fulfilling their changing responsibilities under new rules adopted under the Investment Advisers Act of 1940, as well as new staff interpretations and guidance. For the Second Edition, the original author, Terrance J. Oand’Malley, is joined by John H. Walsh. While both authors are seasoned practitioners and acknowledged experts in the area of investment adviser compliance matters, Mr. Walshand’s years of experience, including at the SEC, are reflected in the enhanced practical discussion of relevant legal and compliance issues, including increased numbers of compliance tips, enforcement and regulatory alerts, and compliance tools. Investment Adviser's Legal and Compliance Guide, Second Edition covers in detail such topics as: Filings and amendments that an adviser must make to maintain its SEC registration Major rules and requirements dealing with marketing and attracting new clients Issues arising in connection with the management of private funds The SEC's examination process New clients, and the management of client accounts. The book also covers requirements relating to the adviser's obligation to its customers, including preventing insider trading and other trading abuses, as well as an adviser's recordkeeping, which is a major factor in meeting the requirements of the Investment Advisers Act. In addition, Investment Adviser's Legal and Compliance Guide, Second Edition provides registered investment advisers and their legal counsel with a comprehensive review of their compliance responsibilities that arise under the Investment Advisers Act.