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6.0 Resource management 6.1 Provision of resources The manufacturing organization shall de...

2023-10-11T04:45:03

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These processes shall be managed by the manufacturer in accordance with the requirements o...

2023-10-10T04:27:15

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10.As provided in the rules, surrogate marker should be considered as an interim data poin...

2023-10-28T05:49:20

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After the NDA is accepted the various section of the application should undergo concurrent...

2023-10-26T11:13:04

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(e) all personnel shall bear clean body covering appropriate to their duties. Smoking, eat...

2023-10-11T04:55:18

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5.6.2 Review input: The input to management review shall include information on— (a) resul...

2023-10-11T04:40:16

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5.0 Management responsibility 5.1 Management commitment Top management of the manufacturer...

2023-10-10T04:35:45

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4. Quality management system 4.1 General The manufacturer shall establish, document, imple...

2023-10-10T04:26:41

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3.18.2 Design validation means establishing by objective evidence that device specificatio...

2023-10-09T05:45:47

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