Author: Publisher:
ISBN:
Category : Cosmetics
Languages : en
Pages : 1628
Book Description
FDA Compliance Policy Guides Manual
Author: FDA Compliance Policy Guides Manual
Author: FDA Compliance Policy Guides Manual
Author: FDA Compliance Policy Guides Manual
Author: United States. Food and Drug AdministrationPublisher:
ISBN:
Category : Cosmetics
Languages : en
Pages :
Book Description
FDA Compliance Policy Guides Manual
Author: United States. Food and Drug AdministrationPublisher:
ISBN:
Category : Cosmetics
Languages : en
Pages :
Book Description
FDA Compliance Policy Guides Manual
Author: FDA Compliance Policy Guides Manual
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.
FDA/ORA Compliance Policy Guides Manual
Author: Publisher:
ISBN:
Category : Food adulteration and inspection
Languages : en
Pages :
Book Description
The purpose of the Compliance Policy Guides (CPG) Manual is to provide a convenient and organized system for statements of FDA compliance policy, including those statements which contain regulatory action guidance information. The statements made in the CPG are not intended to create or confer any rights, privileges, or benefits on or for any private person, but are intended for internal guidance. The CPG Manual is the repository for all agency compliance policy that has been agreed to by the center(s) and the Associate Commissioner for Regulatory Affairs. Examples of sources from which CPGs are prepared include: a) statements or correspondence by headquarters offices or centers reflecting new policy or changes in compliance policy including Office of the Commissioner memoranda, center memoranda and other informational issuances, agency correspondence with trade groups and regulated industries, and advisory opinions; b) precedent court decisions; c) multicenter agreements regarding jurisdiction over FDA regulated products; d) preambles to proposed or final regulations or other Federal Register documents; and f) individual regulatory actions.
FDA Compliance Program Guidance Manual
Author: United States. Food and Drug AdministrationPublisher:
ISBN:
Category : Cosmetics industry
Languages : en
Pages : 36
Book Description