21 CFR Part 11


Book Description

Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places




The REGTECH Book


Book Description

The Regulatory Technology Handbook The transformational potential of RegTech has been confirmed in recent years with US$1.2 billion invested in start-ups (2017) and an expected additional spending of US$100 billion by 2020. Regulatory technology will not only provide efficiency gains for compliance and reporting functions, it will radically change market structure and supervision. This book, the first of its kind, is providing a comprehensive and invaluable source of information aimed at corporates, regulators, compliance professionals, start-ups and policy makers. The REGTECH Book brings into a single volume the curated industry expertise delivered by subject matter experts. It serves as a single reference point to understand the RegTech eco-system and its impact on the industry. Readers will learn foundational notions such as: • The economic impact of digitization and datafication of regulation • How new technologies (Artificial Intelligence, Blockchain) are applied to compliance • Business use cases of RegTech for cost-reduction and new product origination • The future regulatory landscape affecting financial institutions, technology companies and other industries Edited by world-class academics and written by compliance professionals, regulators, entrepreneurs and business leaders, the RegTech Book represents an invaluable resource that paves the way for 21st century regulatory innovation.




Complete Guide to Federal and State Garnishment, 2019 Edition (IL)


Book Description

Complete Guide to Federal and State Garnishment provides much-needed clarity when the federal and state laws appear to conflict. You'll find plain-English explanations of the laws and how they interact, as well as the specific steps you and your staff need to take to respond to the order properly. Numerous detailed examples and mathematical calculations make it easy to apply the law under different scenarios. Written by Amorette Nelson Bryant, who was recently appointed by the Uniform Law Commission as an observer for the Drafting Committee on a Wage Garnishment Act and was a past chair of both the APA GATF Child Support Subcommittee and Garnishment Subcommittee, Complete Guide to Federal and State Garnishment brings the payroll professional up-to-date on the latest federal and state laws and regulations affecting this ever-changing area. It is your one-stop source for answers to critical questions, such as: Does the amount exempt from garnishment change when the minimum wage goes up? How do I determine the wages to which the garnishment applies? If an employee is subject to more than one garnishment, which has priority? Which state's rules do I use when I receive a child support order sent from another state? State or federal law - which applies for creditor garnishment and support? Are there alternatives to remitting withheld child support via EFT/EDI? How do I handle garnishments when employees are paid a draw against salary? Previous Edition: Complete Guide to Federal and State Garnishment, 2018 Edition, ISBN 9781454884255¿




Complete Guide to Human Resources and the Law, 2019 Edition


Book Description

The Complete Guide to Human Resources and the Law will help you navigate complex and potentially costly Human Resources issues. You'll know what to do (and what not to do) to avoid costly mistakes or oversights, confront HR problems - legally and effectively - and understand the rules. The Complete Guide to Human Resources and the Law offers fast, dependable, plain English legal guidance for HR-related situations from ADA accommodation, diversity training, and privacy issues to hiring and termination, employee benefit plans, compensation, and recordkeeping. It brings you the most up-to-date information as well as practical tips and checklists in a well-organized, easy-to-use resource. The 2019 Edition provides new and expanded coverage of issues such as: The Supreme Court held in March 2016 that to prove damages in an Fair Labor Standards Act (FLSA) donning/doffing class action, an expert witness' testimony could be admitted Tyson Foods, Inc. v. Bouaphakeo, 136 S. Ct. 1036 (2016). Executive Order 13706, signed on Labor Day 2015, takes effect in 2017. It requires federal contractors to allow employees to accrue at least one hour of paid sick leave for every 30 hours they work, and unused sick leave can be carried over from year to year. Mid-2016 DOL regulations make millions more white-collar employees eligible for overtime pay, by greatly increasing the salary threshold for the white-collar exemption. Updates on the PATH Act (Protecting Americans From Tax Hikes; Pub. L. No. 114-113. The DOL published the "fiduciary rule" in final form in April 2016, with full compliance scheduled for January 1, 2018. The rule makes it clear that brokers who are paid to offer guidance on retirement accounts and Individual Retirement Arrangements (IRAs) are fiduciaries. In early 2016, the Equal Employment Opportunity Commission (EEOC) announced it would allow charging parties to request copies of the employer's position statement in response to the charge. The Supreme Court ruled that, in constructive discharge timing requirements run from the date the employee gives notice of his or her resignation--not the effective date of the resignation. Certiorari was granted to determine if the Federal Arbitration Act (FAA) preempts consideration of severing provisions for unconscionability. Previous Edition: Complete Guide to Human Resources and the Law, 2018 Edition ISBN 9781454884309




Software Change and Configuration Management A Complete Guide - 2019 Edition


Book Description

When doing a DR drill, have you found the run book to be out of sync with the current configuration? How many man-hours can be recovered through effective configuration management? Do you need a new release, version or patch level of the software? Is the service usage appropriate to capacity? Defining, designing, creating, and implementing a process to solve a challenge or meet an objective is the most valuable role… In EVERY group, company, organization and department. Unless you are talking a one-time, single-use project, there should be a process. Whether that process is managed and implemented by humans, AI, or a combination of the two, it needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?' This Self-Assessment empowers people to do just that - whether their title is entrepreneur, manager, consultant, (Vice-)President, CxO etc... - they are the people who rule the future. They are the person who asks the right questions to make Software Change and Configuration Management investments work better. This Software Change and Configuration Management All-Inclusive Self-Assessment enables You to be that person. All the tools you need to an in-depth Software Change and Configuration Management Self-Assessment. Featuring 965 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which Software Change and Configuration Management improvements can be made. In using the questions you will be better able to: - diagnose Software Change and Configuration Management projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices - implement evidence-based best practice strategies aligned with overall goals - integrate recent advances in Software Change and Configuration Management and process design strategies into practice according to best practice guidelines Using a Self-Assessment tool known as the Software Change and Configuration Management Scorecard, you will develop a clear picture of which Software Change and Configuration Management areas need attention. Your purchase includes access details to the Software Change and Configuration Management self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows your organization exactly what to do next. You will receive the following contents with New and Updated specific criteria: - The latest quick edition of the book in PDF - The latest complete edition of the book in PDF, which criteria correspond to the criteria in... - The Self-Assessment Excel Dashboard - Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation - In-depth and specific Software Change and Configuration Management Checklists - Project management checklists and templates to assist with implementation INCLUDES LIFETIME SELF ASSESSMENT UPDATES Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.




The Regulatory Compliance Matrix: Regulation of Financial Services, Information and Communication Technology, and Generally Related Matters


Book Description

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."




Determann’s Field Guide to Data Privacy Law


Book Description

Companies, lawyers, privacy officers, compliance managers, as well as human resources, marketing and IT professionals are increasingly facing privacy issues. While plenty of information is freely available, it can be difficult to grasp a problem quickly, without getting lost in details and advocacy. This is where Determann’s Field Guide to Data Privacy Law comes into its own – identifying key issues and providing concise practical guidance for an increasingly complex field shaped by rapid change in international laws, technology and society




Data Protection Implementation Guide


Book Description

The complexities of implementing the General Data Protection Regulation (GDPR) continue to grow as it progresses through new and ever-changing technologies, business models, codes of conduct, and decisions of the supervisory authorities, and the courts. This eminently practical guide to implementing the GDPR – written in an original, problem-solving style by a highly experienced data protection expert with equal knowledge of both law and technology – provides a step-by-step project management approach to building a GDPR-compliant data protection system, assessing, and documenting the risks and then implementing these changes through processes at the operational level. With detailed attention to case law (Member State, ECJ, and ECHR), especially where affecting high-risk areas that have attracted scrutiny, the guidance proceeds systematically through such topics and issues as the following: required documentation, policies, and procedures; risk assessment tools and analysis frameworks; children’s data; employee and health data; international transfers post-Schrems II; data subject rights including the right of access; data retention and erasure; tracking and surveillance; and effects of technologies such as artificial intelligence, biometrics, and machine learning. With its practical examples derived from the author’s experience in building GDPR-compliant software, as well as its analysis of case law and enforcement priorities, this incomparable guide enables company data protection officers and compliance staff to advise on key issues with full awareness of the legal and reputational risks and how to mitigate them. It is also sure to be of immeasurable value to concerned regulators and policymakers at all government levels. “…it's going to be the go to resource for practitioners.” Tom Gilligan, Data Protection Consultant, September 2021 "I purchased this book recently and I’m very glad I did. It’s the textbook I have been waiting for. As someone relatively new to data protection, I was finding it very difficult to find books on the practical side of data protection. This book is very clearly laid out with practical examples and case law given for each topic, which is immensely helpful. I would recommend it to any data protection practitioners." Jennifer Breslin, LLM CIPP/E, AIPP Member




Electrical Product Compliance and Safety Engineering


Book Description

This comprehensive resource is designed to guide professionals in product compliance and safety in order to develop more profitable products, contribute to customer satisfaction, and reduce the risk of liability. This book analyzes the principles and methods of critical standards, highlighting how they should be applied in the field. It explores the philosophy of electrical product safety and analyzes the concepts of compliance and safety, perception of risk, failure, normal and abnormal conditions, and redundancy. Professionals find valuable information on power sources, product construction requirements, markings, compliance testing, and manufacturing of safe electrical products.




Does Compliance Matter in Special Education?


Book Description

This book asks a question that many educators may think, but won’t say out loud: Does compliance with IDEA legislation matter? The author acknowledges that, while compliance with IDEA (Individuals with Disabilities Education Act) is important, it can also be an administrative burden that detracts from practitioners’ capacity to adequately serve students with disabilities. Using data collected from three suburban school districts, Voulgarides helps us to understand how compliance with IDEA intersects with decades of evidence of racial inequities in student outcomes. This timely and thought-provoking book unpacks the civil rights history of IDEA, examines the impact of its procedural focus on educational practice, and questions why racial inequities in special education persist despite good intentions by policymakers, educators, and school personnel. Book Features: Uses empirical evidence to examine the common assumption that compliance with IDEA leads to educational equity. Focuses on the different dimensions of the equity concern that lie at the intersection between race, disability, and educational policy. Challenges practitioners to think about the roles they play in both the production and the disruption of educational inequities.