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GO: Message displayed for Unlimited MetroCards. GO. 1 RIDE LEFT: Message displayed for Student MetroCards, where 1 is the number of rides left for the day. JUST USED: The passback period for the unlimited MetroCard is not up. GO. 1 XFER OK: Message displayed when transferring from a bus.

Although mass and exible (or lean ) production systems implicitly require different approaches to managing human resources, Womack et al. did not explain how HR practices are integrated into these different production systems, nor did they test the relationship between HR practices and performance. Indeed, the term lean production

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If a device manufacturer makes a change that could affect the safety or effectiveness of the device for which the applicant has an approved PMA, the applicant must submit a PMA supplement for review and approval58 The FDA might require additional studies to demonstrate that no adverse effect results from the change CBER has a similar process for manufacturers wishing to change products marketed under a BLA FDA Regulation of New Versions of Other Technologies Technological advances in medicine have ushered in a variety of new improvements to traditional drugs, devices, and biologics In some cases, the task of acquiring the data necessary to obtain approval for an improvement technology is relatively simple For example, the FDA did not have too much heart burn in approving the use of antibiotics in bone cement.

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time. Time it takes to complete the task. To keep things simple, we can assume all resources are occupied while the task is in progress. It may be dif cult to come up with a precise duration for the tasks. A good modeling tool will let you specify a ballpark gure using a probability distribution model. We are now ready to move to the simulation phase.

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Within 5 to 10 years, almost everyone will be scanned multiple times daily: at the front door of the office and at one s desk; at the door to one s home and behind the wheel of one s car; on the street and on the telephone In a world where one s next customer, partner, or enemy may be located anywhere on the planet, some universal means of identifying almost everyone uniquely is required Biometric identification of one sort or another is the likeliest means It won t be used sparingly The tools are too useful even to the people who think it s too much to imagine that it will be otherwise.

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59 In other cases, negotiating data requirements with the agency and garnering the necessary data can be a regulatory nightmare The data required for safety and efficacy of a new version of a product is relatively subjective When there are no guidance documents, FDA reviewers have substantial discretion Often, in erring on the side of caution, reviewers tend to request additional clinical data when there is sound scientific basis for approving the newer version without additional information Even when a new technology slightly modifies the functionality of an approved technology, all hell [can] break[] loose in securing regulatory approval60 A company improving an existing technology, with ample evidence of safety and efficacy, might find itself conducting a whole new round of clinical trials FDA has long dealt with the issue of newer versions of existing technologies and has utilized different tools to smooth the path to regulatory approval.

authoritarian and male-dominated. They re not likely to force heavy restrictions on new businesses, especially if those businesses are competing with American companies that can do anything they like where information is concerned. They ll consider information to be the rightful property of the people in charge in both the public and private sectors. There will be few legal or regulatory restrictions on information ownership and use in developing nations during the next 10 years.

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