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Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.
Thomas Fox, the Compliance Evangelist, is one of the leading writers, thinkers and commentators on the nuts and bolts of compliance. His always practical advice is now available in one volume, The Complete Compliance Handbook. This book incorporates the most recent pronouncements and guidance from the Department of Justice, including 2017's Evaluation of Corporate Compliance Programs and FCPA Corporate Enforcement Policy, to provide the most up-to-date advice on what constitutes a best practices compliance program. In this single volume compendium, Fox brings together the tops ideas, topics and techniques you can incorporate your compliance program, literally in 31-days to more fully operationalize your compliance regime. If you want one volume to guide you in operationalizing compliance, this is it. The book is designed to provide you with a step-by-step guide to the design, creation, implementation of or enhancement to a compliance program. It begins with 31-days to a more effective compliance program. Each entry presents one thing you can accomplish, at little to no cost, to improve any level of compliance program. There are three key-takeaways for each entry. The final chapter goes through the same process for you to operationalize your compliance program. In between these bookends, The Complete Compliance Handbook features chapters on: -Operationalizing Compliance Through Human Resources -The Role of the Board of Directors and Compliance -360-Degrees of Communication in Compliance -Better Third-Party Risk Management -Reporting and Investigations -Internal Controls -Innovation in Compliance -Written Standards -More Effective Compliance for Business Ventures -Continuous Improvement The author, Thomas Fox, has written 15 books on compliance, leadership and business ethics. He founded the Compliance Podcast Network and has one of the largest social media presences in compliance. He has worked in the compliance arena for over 10 years and draws upon his many years of experience in the profession to create this single volume which will become the standard 'nuts and bolts' text on compliance. Fox's writing style is suited for any skill level of compliance practitioner or maturity of corporate compliance program.
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.