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.
Compressed air systems are the third most important utility to industry and are commonly the most misunderstood. Written to appeal to operators, mechanics and junior engineers, this manual is designed to provide a solid understanding of common compression systems and operations techniques. Using this book, the users learn tips and techniques for: creating a baseline of system performance, determining the impact of different compressors and compressor control types for the job at hand, and learning basic approaches to general maintenance.
One of Fuller’s most popular works, Operating Manual for Spaceship Earth, is a brilliant synthesis of his world view. In this very accessible volume, Fuller investigates the great challenges facing humanity. How will humanity survive? How does automation influence individualization? How can we utilize our resources more effectively to realize our potential to end poverty in this generation? He questions the concept of specialization, calls for a design revolution of innovation, and offers advice on how to guide “spaceship earth” toward a sustainable future. Description by Lars Muller Publishers, courtesy of The Estate of Buckminster Fuller
"It's easy to dream of owning your own brewery, but where do you begin? This Brewery Operations Manual is a complete 'to do' list that will guide you through the maze of events necessary to open your own brewery. This is not a 'how I did it' story, rather the real nuts and bolts stuff on how you can do it, without spending the family fortune!"--Cover [p. 4].
Over the last 30 years, wages have stagnated and average household debt has more than doubled. People are forced to take on debt to meet their everyday needs like housing and education, leading to devastated communities and an increasing reliance on credit to maintain basic living standards. This system enriches the lives of few at the expense of many. The Debt Resisters' Operations Manual is a handbook for debtors everywhere to understand how the debt system really works, while providing practical tools for fighting debt in its most exploitative forms.
At last! A beginner's guide to newborn baby technology, complete with step-by-step instructions, FAQs, and schematics, from a board-certified pediatrician and his son (an older model). Congratulations—you’ve just acquired one of life’s biggest technological marvels: a newborn baby! New owners have so many questions: How do I handle sleep malfunctions? When should I bring the baby to a doctor for servicing? What transportation accessories do I need? New users will get plenty of useful advice on: PREPARATION AND HOME INSTALLATION: How to store your baby properly GENERAL CARE: Effective techniques for handling, holding, and comforting the baby FEEDING: An in-depth guide to your baby’s power supply, from breastfeeding to solid food PROGRAMMING SLEEP MODE: How to Configure baby’s sleeping area and manage issues such as overstimulation GENERAL MAINTENANCE: Keep that new baby smell fresh with tips on sanitation and care, such as diaper installation and cleaning GROWTH AND DEVELOPMENT: Perform user testing on baby’s reflexes, note and track milestones, plus advanced motor and sensory skills SAFETY AND EMERGENCY MAINTENANCE: Monitor baby’s health, tackle childproofing, learn life-saving procedures, plus get fixes for minor issues such as cradle cap and diaper rash Whatever your concerns, celebrated pediatrician Dr. Louis Borgenight and his son, Joe Borgenicht, provide plenty of useful advice for anyone who wants to learn the basics of childcare.
Filled with procedures for successfully managing construction operations, this work features over 300 pages of methods, strategies and tactics, forms and ready-to-copy letters all laid out in a concise, easy-to-grasp style. Devoted to the design-build process, it also offers coverage of the advances in claims and dispute resolution.
Samurai Warrior Operations Manual examines the Samurai world: the moral and psychological development of the warrior, the ethical standards they were meant to uphold, their training in both martial arts and strategy, and the enormous role that the traditions of Shintoism, Buddhism, Confucianism, and Taoism had in influencing samurai ideals. It also examines the more personal aspects of a Samurai warrior: what they ate, how they dressed, the weapons they used, their battle tactics, and the fascinating details of their day to day life.
Only recently, the physician setting up his own practice was considered an anachronism. And doctors loosely affiliated with an independent practice association (IPA) fared no better. Lacking capital, financial management, and the mechanisms for adequate medical and information system management, many IPAs around the country were coping with financial instability. From the outset, IPAs seemed doomed to obsolescence by the organizational efficiencies and superior resources of third-party payors. Yet, in the early 1990s, IPAs underwent a remarkable turnaround?building infrastructure, investing in MIS systems, and accepting risk?transforming themselves into genuine competitors in healthcare quality and efficiency with HMOs. In fact, IPAs have become an increasingly common healthcare delivery model, offering distinct advantages over other payors to physicians interested in the administrative gains and security of a group practice, while still retaining their autonomy. Healthcare Financial Operations Manual for Independent Practice Associations is the first comprehensive guide to setting up an IPA, detailing the many operational, legal, and logistical complexities of managing a physician-owned organization. Since controlling the financial and tax aspects of an IPA is critical to its survival, the Manual addresses an entire range of financial accounting concerns, including accounting concepts and methods for an IPA, internal control procedures, insurance issues, tax issues, policy guidance, and profit-making issues. Specific topics addressed include: How to manage and report primary, specialty, and inpatient care How to credential IPA providers How to negotiate contracts for single specialty and multispecialty IPAs Antitrust laws and IPAs?with a case study of a Florida IPA Why IPAs fail The book also clearly outlines how to acquire and negotiate a managed care contract and, with the help of its disk, provides a host of checklists, forms, and five sample contracts (not included in the book) that allow the user to chart his or her progress and get quickly up to speed on the essential paperwork. The Manual also provides hands-on advice on setting up an efficient computer system for an IPA, reflecting the acknowledged role of a first-rate information system in an IPA?s success. Offering candid, real-world guidance on setting up and successfully administering an IPA, Healthcare Financial Operations Manual for Independent Practice Associations is the complete reference to making an IPA work?for both doctor and patient. JAMES W. KARLING, CPA, is founder and President of Karling & Associates, an eighteen-person CPA firm located in San Ramon, California, which specializes in providing consulting and accounting services to the healthcare and managed care industry. Prior to founding Karling & Associates in 1994, Jim was a partner for eighteen years with Ernst & Young and has also been National Director of Arthur Young & Company?s healthcare practice. He has been a frequent speaker at healthcare programs and seminars and has published a number of articles on healthcare financial issues. REED TINSLEY, CPA, is director of Horne CPA Group?s Physician Services Division. His entire practice is centered in the healthcare industry and he works closely with physicians, medical systems, and other delivery systems with managed care contracting issues. A leading speaker on a variety of healthcare topics, his seminars have been sponsored by the American Medical Association. He is cochair of the CPA section of the IPA Association of America and the author of Performing an Operational and Strategic Assessment of a Medical Practice and Valuation of a Medical Practice, also from Wiley. JOE D. HAVENS, CPA, is shareholder in charge of the Horne CPA Group?s Hattiesburg, Mississippi, office and a member of its board of directors. He heads a team of healthcare consultants to physicians, medical groups, IPAs, hospitals, and managed care organizations as they develop strategies for healthcare reform. Havens also recently completed a five-part video series on healthcare subjects sponsored by Westcott Communications that is being promoted nationally to CPAs, consultants, and healthcare professionals. He coauthored the IPA Association of America?s Financial Accounting Manual for IPAs. The IPA finally comes of age?in the first comprehensive guide to successfully managing one In only a few short years, independent practice associations (IPAs) have been able to transform themselves?shedding their image as a healthcare delivery system ranking a distant second to HMOs. Revitalized with a new infrastructure, improved medical management and information systems, and forms of risk assumption, the IPA is suddenly marketable. Expanded geographic coverage, lower overhead, and a wide range of specialties are only part of the reason. Its other advantages?practical and administrative?are detailed in the first comprehensive guide to setting one up and making it work: Healthcare Financial Operations Manual for Independent Practice Associations. Focusing largely on survival issues, the Manual addresses a host of key financial accounting concerns, including accounting concepts and methods for an IPA, internal control procedures, insurance issues, tax issues, policy guidance, and profit-making issues, including such specifics as: Management tools and reporting for primary, specialty, and inpatient care Credentialing IPA providers Risk pool accounting and auditing Also clearly outlined are tips on how to acquire and negotiate a managed care contract (for both single specialty and multispecialty IPAs) as well as hands-on advice on setting up an efficient, first-rate claims payment system. And the book?s disk provides a complete package of checklists, forms, and five sample contracts (not included in the book) essential to managing an IPA. The book also includes a summary "Physician and IPA Toolkit" appendix, offers cautionary advice on why IPAs fail, and describes the current status of antitrust laws and IPAs. Healthcare Financial Operations Manual for Independent Practice Associations is a complete primer to setting up what is now one of the most efficient and cost-effective healthcare delivery systems available, one that meets the bottom-line needs of both doctor and patient.
