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.

Often thought of as a subdialect of American "governmentese," FDA-Speak is a language unique to healthcare regulators and those regulated. If you have any involvement with the US Food and Drug Administration, or if they have involvement with you, you need to speak the language. This revised and updated edition of FDA-Speak retains the original easy

The rapid development of HPLC instrumentation and technology opens numerous possibilities - and entails new questions. Which column should I choose to obtain best results, which gradient fits to my analytical problem, what are recent and promising trends in detection techniques, what is state of the art regarding LC-MS coupling? All these questions are answered by experts in ten self-contained chapters. Besides these more hardware-related and technical chapters, further related areas of interest are covered: Comparison of recent chromatographic data systems and integration strategies, smart documentation, efficient information search in internet, and tips for a successful FDA inspection. This practical approach offers in a condensed manner recent trends and hints, and will also display the advanced reader mistakes and errors he was not aware of so far.