Author: Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 40
Book Description
FDA Inspection Operations Manual
Author: FDA Inspection Operations 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 Inspections Operations Manual
Author: United States. Department of Health and Human ServicesPublisher:
ISBN:
Category : Health & Fitness
Languages : en
Pages : 172
Book Description
FDA Inspections Operations Manual
Author: Betats-UnisPublisher:
ISBN: 9780914176121
Category :
Languages : en
Pages : 76
Book Description
FDA Inspection Operations Manual
Author: United States. Food and Drug AdministrationPublisher:
ISBN:
Category :
Languages : en
Pages : 184
Book Description
FDA Inspection Operations Manual
Author: United States. Food and Drug AdministrationPublisher:
ISBN:
Category : Drugs
Languages : en
Pages : 0
Book Description
Investigations Operations Manual
Author: Mindy J. Allport-SettlePublisher: Pharmalogika
ISBN: 9780982147627
Category :
Languages : en
Pages : 800
Book Description
The IOM is the primary guidance document on FDA inspection policy and procedures for field investigators and inspectors. This extends to all individuals who perform field investigational activities in support of the Agency's public mission. Accordingly, it directs the conduct of all fundamental field investigational activities. Adherence to this manual is paramount to assure quality, consistency, and efficiency in field operations. The specific information in this manual is supplemented, not superseded, by other manuals and field guidance documents. The IOM is recommended reading for all operations regulated by the Food and Drug Administration.
FDA Inspection Operations Manual
Author: United States. Department of Health and Human ServicesPublisher:
ISBN: 9780914176268
Category : Food law and legislation
Languages : en
Pages : 355
Book Description
FDA Establishment Inspections
Author: Mindy J. Allport-SettlePublisher: Pharmalogika
ISBN: 9780982147665
Category : Technology & Engineering
Languages : en
Pages : 358
Book Description
Establishment Inspections, Chapter 5 of the FDA's Investigations Operations Manual, details every step FDA inspectors are required to follow when conducting a facility inspection. This text is a comprehensive reference for regulatory inspections and is useful as an introduction to the practical components of the FDA-regulated industries or as a refresher. While the specific regulations and requirements may differ widely between pharmaceutical, biotechnology, medical device, and food manufacturers, the inspection processes and procedures do not.
