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FDA QSR入門セミナー

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電子生データの留意点

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Annex 15: Qualification and Validation(邦訳)

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Importance of Clinical Evaluation

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4 QSR関係(製造管理編) 不適合品

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改正GMP省令で作成すべき手順書

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21 CFR Part 801 Labeling

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