Post list for FDA QSR

FDA QSR

【FDA CFR 820 QSR Compliance】 Logistics Management Provision and Procedure

¥400

FDA QSR

【FDA CFR 820 QSR Compliance】 Inspection, measuring, and test equipment Management Provision

¥200

FDA QSR

【FDA CFR 820 QSR Compliance】Inspection, measuring, and test equipment Management Procedure, and Forms

¥300

FDA QSR

【FDA CFR 820 QSR Compliance】Contamination control Procedure

¥200

FDA QSR

【FDA CFR 820 QSR Compliance】Document Management Provision,Procedure, and Forms

¥500

FDA QSR

【FDA CFR 820 QSR Compliance】Training Provision, Procedure, and Forms

¥500

FDA QSR

【FDA CFR 820 QSR Compliance】Process Design Procedure and Forms

¥300

FDA QSR

【FDA CFR 820 QSR Compliance】Quality Manual

¥500

FDA QSR

【FDA CFR 820 QSR Compliance】Acceptance Activities Provision, Procedure, and Forms

¥500

FDA QSR

【FDA CFR 820 QSR Compliance】Packaging and Labeling Management Provision

¥200

FDA QSR

【FDA CFR 820 QSR Compliance】Quality Audit Provision, Procedure, and Forms

¥500

FDA QSR

【FDA CFR 820 QSR Compliance】Working Environment Management Procedure

¥200

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2 QSR関係20150618 21 CFR 820 QSR概要

重たいQMS

QSIT 設計管理サブシステムにおいてFDA 査察を準備する際の留意事項

製薬企業ではなぜCAPAの導入が遅れているのか？

品質リスクマネジメントについて

IOQの実施について

品質マニュアル

ICH Q8 製剤開発に関するガイドライン（平成18年9月1日、薬食審査発第0901001号）

FDA査察対応セミナー 6章

保存とは

改正GMP省令の問題点

カイゼンとは

FDA QSR

【FDA CFR 820 QSR Compliance】 Logistics Management Provision and Procedure

【FDA CFR 820 QSR Compliance】 Inspection, measuring, and test equipment Management Provision

【FDA CFR 820 QSR Compliance】Inspection, measuring, and test equipment Management Procedure, and Forms

【FDA CFR 820 QSR Compliance】Contamination control Procedure

【FDA CFR 820 QSR Compliance】Document Management Provision,Procedure, and Forms

【FDA CFR 820 QSR Compliance】Training Provision, Procedure, and Forms

【FDA CFR 820 QSR Compliance】Process Design Procedure and Forms

【FDA CFR 820 QSR Compliance】Quality Manual

【FDA CFR 820 QSR Compliance】Acceptance Activities Provision, Procedure, and Forms

【FDA CFR 820 QSR Compliance】Packaging and Labeling Management Provision

【FDA CFR 820 QSR Compliance】Quality Audit Provision, Procedure, and Forms

【FDA CFR 820 QSR Compliance】Working Environment Management Procedure

Revised Guidance for Computer Systems Used in FDA Clinical Trials

Flow of FDA inspections from implementation to completion

Data Integrity and Human Error

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