Author: Publisher:
ISBN:
Category :
Languages : en
Pages : 56
Book Description
FDA Compliance Program Guidance Manual, Transmittal No. 00-07, January 3, 2000
Author: FDA Investigations Operations Manual
Author: Food and Drug AdministrationPublisher:
ISBN: 9780865879737
Category : Drugs
Languages : en
Pages : 0
Book Description
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.
The CMS Hospital Conditions of Participation and Interpretive Guidelines
Author: Publisher:
ISBN: 9781683086857
Category :
Languages : en
Pages : 546
Book Description
In addition to reprinting the PDF of the CMS CoPs and Interpretive Guidelines, we include key Survey and Certification memos that CMS has issued to announced changes to the emergency preparedness final rule, fire and smoke door annual testing requirements, survey team composition and investigation of complaints, infection control screenings, and legionella risk reduction.
Registries for Evaluating Patient Outcomes
Author: Agency for Healthcare Research and Quality/AHRQPublisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385
Book Description
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Freedom of Information Act Guide
Author: Publisher:
ISBN:
Category : Freedom of information
Languages : en
Pages : 1146
Book Description
United States Attorneys' Manual
Author: United States. Department of JusticePublisher:
ISBN:
Category : Justice, Administration of
Languages : en
Pages : 720
Book Description
Guide to the Freedom of Information Act
Author: Publisher: Government Printing Office
ISBN:
Category : Law
Languages : en
Pages : 920
Book Description
Contains an overview discussion of the Freedom of Information Act's (FOIA) exemptions, its law enforcement record exclusions, and its most important procedural aspects. 2009 edition. Issued biennially. Other related products: Report of the Commission on Protecting and Reducing Government Secrecy, Pursuant to Public Law 236, 103d Congress can be found here: https: //bookstore.gpo.gov/products/sku/052-071-01228-1 Overview of the Privacy Act of 1974, 2015 Edition can be found here: https: //bookstore.gpo.gov/products/sku/027-000-01429-1
ORI Introduction to the Responsible Conduct of Research
Author: Nicholas Hans SteneckPublisher: Government Printing Office
ISBN:
Category : Medical research personnel
Languages : en
Pages : 188
Book Description
Toxicological Profile for Chlordane
Author: Instructions to Surveyors
Author: Great Britain. Board of TradePublisher:
ISBN:
Category : Load-line
Languages : en
Pages : 98
Book Description