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Each observer is given a set of sample training images from which they are trained in four steps: (1) learn how to interpret an image with softcopy display, (2) read the assigned softcopy set from LCD, (3) complete the ROC form for the softcopy reading results (eg, see Fig 187), (4) read the assigned hardcopy lm using a light box, and (4) complete a second ROC form for the hardcopy reading results 18834 Observer Viewing Sequences An experimental design is needed to cancel the effects due to the orders in which images are interpreted The images selected can be randomized and divided into four subsets (A, B, C, and D), containing approximately equal numbers of images per subset Identical subsets are included in both hardcopy and softcopy viewing But softcopy and hardcopy can not be mixed in the same subset.

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Each observer participates in two rounds of interpretation Round 1 consists of four sessions as shown in Table 1812 (but it depends on the total number of images in the ROC study) During each session either the softcopy subset or the hardcopy subset is read To minimize fatigue, each observer interprets about 30 images of the same kind (ie, either hard or softcopy) during a session In round 1, the assigned observers interpret all four subsets, half from hard copy and the other.

P1: FCH WY050-12 WY050-Ulick-v4 September 19, 2004 12:5

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Subsystems must be pertinent to the speci c quality system being audited and may coincide with major elements of a standard to which the quality system is intended to conform or the major elements identi ed in the FDA pharmaceutical QS guidance. When using the top-down approach, the auditor will rst review each subsystem to determine if the requirements that apply to that subsystem (e.g., regulatory requirements, the requirements of the standard) are met by de ning, documenting, and implementing appropriate procedures. Once the auditor has veri ed that the requisite procedures are in place, he or she will review the associated records and other documents to verify that the procedures have been followed and documented and that the quality system is functioning effectively as designed and conforms to applicable regulatory requirements and standards. This approach allows for a systematic evaluation of each subsystem and can be as detailed as needed. A bottom-up approach may be used to follow up on a speci c quality problem identi ed from trend analyses, product nonconformities, adverse experiences, customer complaints, or other sources of quality data. Starting with quality records associated with the problem, the auditor will work his or her way up through the

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Figure 4.16 UTRAN-end MAC architecture/MAC-hs details [28], [29].

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If you ever completely muck up the palettes or a palette somehow gets stuck under the menu bar choose Window Reset Palette Locations.

Frequency (GHz)

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