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FDA's New Supply Chain Strategy Calls for Global Regulators |
Материал из категории News of logistics (in English) |
24.06.2011 23:06 |
Метки (тэги, tags): The U.S. Food and Drug Administration has announced a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain. The strategy is outlined in a report called the Pathway to Global Product Safety and Quality. “Global production of FDA-regulated goods has exploded over the past ten years,” says Dr. Margaret Hamburg, Commissioner of Food and Drugs. “In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their
The FDA report calls for the agency to transform the way it conducts business and to act globally in order to promote and protect the health of 1. The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality. 2. The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets. 3. The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology. 4. The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk. "FDA regulated imports have quadrupled since 2000,” The change in strategy will address trends expected to be seen worldwide in upcoming years: - Western economies will increase their productivity to compete with emerging markets and economies, leading to more imports and increased pressure to reinvent manufacturing processes. - Money, goods, data and people will increasingly and more quickly cross borders. Today, a typical - Growing demand, constrained supply, and increased regulatory and social scrutiny will determine what resources are used, how they are used, and the cost. Manufacturers will adopt new manufacturing processes and emerging technologies in response. - Governments worldwide will increasingly be called upon to mitigate the sometimes negative impacts of globalization on their citizens, making the operating environment for companies more complex. The new strategy also builds on changes already set in motion by the FDA. The FDA increased the number of foreign drug manufacturing inspections by 27% between 2007 and 2009 and has opened a series of international offices in key locations. The FDA has also collaborated with its counterparts in the European Union and The FDA is also broadening its food safety efforts under the FDA Food Safety Modernization Act (FSMA). This new law creates a new foods safety system, in which the FDA has a legislative mandate to require comprehensive preventive controls across the food supply chain and has new tools to hold players in the supply chain responsible. There are also new inspection mandates, including a mandate leading to the inspection of more than 19,000 foreign food facilities in the year 2016. The FSMA recognizes the importance of partnerships in the success of this new food safety system, particularly in the area of imports. For example, importers now have an affirmative obligation to verify the safety of the food they bring into the
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