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"This manual contains all the information you need to prepare your own staff manual, regardless of the size of your firm"--
Administrative office procedures may not be glamorous, but they are essential to the success of any enterprise. A well run office reduces miscommunications and helps to eliminate common errors. By making the administrative office a priority, you will establish clear policies and procedures with employee understanding and buy-in, which ensures that your work environment runs smoothly.
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.