FDA Investigations Operations Manual


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.




Environmental Priorities and Poverty Reduction


Book Description

Environmental degradation is associated with increased morbidity and mortality and decreased productivity. Urban and indoor air pollution; inadequate water supply, sanitation, and hygiene; natural disasters (mainly floods and landslides); and land degradation are the environmental problems associated with the highest social and economic costs, falling most heavily on vulnerable people, especially poor children under five years old. This book begins by exploring institutional change and environmental priorities in Colombia over the past 50 years, a time of substantial progress in environmental protection and rapid transition from a largely rural to a highly urbanised economy. Part 2 assesses the burden of disease rooted in inadequate water supply, sanitation, and hygiene; poor air quality; and natural disasters; and the environmental management practices to reduce that burden. A discussion of the environmental costs of rapid and unplanned urbanisation is also included. Part 3 assesses the sustainable management of Colombia's rich endowment of natural resources.







Chavis V. Fairman


Book Description




Poland After Solidarity


Book Description

The unexpected emergence of the Solidarity movement in Poland has focused Western attention on conflicts within socialist states. The rapid truncation of Solidarity and the rise of a new image of the state as a militarized, relatively autonomous, repressive apparatus has left several theoretical questions unresolved and raised some new ones. This volume draws from historical and political accounts of the events that haunted Poland between 1980 and 1984, providing a complex sociological explanation of the major processes that occur within the state-society sphere of relationships. In part one, the authors examine the conflict between social movements and the state in Poland: the history of Solidarity, the nature of the political conflict between Solidarity and the Communist state, the institutionaliza-tion of the means of control by the party over society, the functioning of civil society, and the mediating role of the Catholic Church. In part two, the authors treat issues that go beyond Solidarity: the scope of state autonomy, legitimacy conflicts within socialist and capitalist states, other social movements in Poland, and the philosophical symbolism of Solidarity.




Public general laws


Book Description







Four by Truffaut


Book Description

From the film director behind his creation, Four gives readers an exclusive look at the adventures of Antoine Doinel through the screenplays and stills of the four films he appears in. Thought by many to be the fictional alter ego of Francois Truffaut, Antoine Doinel, played in all movies by Jean-Pierre Leaud, was a fictional character created by Truffaut that depicted many of his own memories ranging from childhood through divorce. Four is an enchanting look at the character of Antoine through screenplays and stills from four of Truffaut’s most well-known films: The 400 Blows, Love at Twenty, Stolen Kisses, and Bed and Board.




Critical Issues in Global Health


Book Description

This compendium of essays written by international health experts describes the opportunities and hazards in improving the health of the world's people. Included is a chapter by Harvard's Jessica Stern on extremist terrorism as a global threat.