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process (planning, management, coordination, etc.) and content (design, engineering, manufacture, drug/device interaction, and so on). The reviews can help to identify problems and to suggest solutions. The ideal reviewer is familiar with the basic project objectives, unconnected with the detailed content or process of the project (thus, independent and fresh), and expert and experienced in carrying out similar projects (and so, best qualified to spot potential or real problems and to offer good advice). |
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The team can use a vast array of tools that carry out each individual function effectively. These include Design for Manufacturing; Design for Assembly; Value Engineering; Finite Elements Analysis; Mold Flow Analysis; Cost Prediction; Production Line Modeling, etc. The project manager should ensure that the appropriate tools are used at the right time and that the results are acted on. |
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The development of any drug delivery device must be properly documented to satisfy regulatory authorities. Because the demands of regulators in different countries differ and demands are constantly developing, it is difficult to predict, with any certainty, what an individual case will require. Frequently, the decision about whether the device should follow the device or the drug route to regulatory approval is taken relatively late. Consequently, it is as well to start documenting properly as early as possible in the project. The device development has some additional areas of documentation required when compared with the development of a new chemical entity. For example, the discipline of configuration control should be applied early. This requires proper control of part drawings, assembly instructions, and so on. This aspect of developments is frequently slapdash resulting in confusion and unnecessary work during the development and regulatory embarrassment at the end. |
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The most critical skill of the device development project manager is the ability to coordinate the activities of many skills in the three major skill groupings, of which two might be in an organization outside the project manager's own. To do this requires awareness of many disciplines, under- |
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