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日本代购-医薬品の品質試験における信頼性基準適用の考え方と問題事例
  • ecompliance:10000023
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日本代购-講師 株式会社東レリサーチセンター 元医薬信頼性保証室長  川口 謙(かわぐち けん)氏 総収録時間 277分 納品方法 セミナー映像・資料はDVDで納品いたします。 出版社 株式会社イーコンプレス 出版年月日 2020年7月17日 内容情報 1.申請資料の信頼性の基準の3要件  1.1 信頼性確保の基本  1.2生データに関する信頼性確保の課題と3要件  1.3「申請資料の信頼性の基準」が制定された経緯 2.信頼性確保の課題  2.1 品質システムの構築  2.2 チェック体制(QAとQC)  2.3 品質向上、維持の課題(教育訓練ほか) 3.生データの定義  3.1 生データとは  3.2 データ区分の明確化 4.データ及び記録の取扱いと問題事例の紹介  4.1 データと記録  4.2 訂正などの方法  4.3 データの確認と承認  4.4 生データの保存     4.4.1 試験に関する生データ     4.4.2 機器や施設に関する生データ     4.4.3 生データの複写   4.5 初心者が犯しやすいミス 5.ワークシート,データファイルの取扱い  5.1 ワークシートの設計  5.2 実験ノートの運用  5.3 試験記録の取扱い 6.「信頼性の基準」適用試験の手順と品質を向上させるための施策  6.1 SOPの整備と機器の保守管理  6.2記録の徹底   6.3 セルフチェックと第3者チェック  6.4予期せぬ出来事への対応、再測定と不採用データ  6.5 教育訓練と資格認定 7.電磁的データ及びCSV(ごく簡単に)  7.1 電磁的データでまず用意すべき文書  7.2 Part11及びER/ESとCSVの関係  7.3 GAMP5  7.4 CSV実施の手順の概略 8.データインテグリティ  8.1 データインテグリティとは  8.2 データの完全性とは  8.3 なぜ今、データインテグリティか?  8.4 ALCORとは(データインテグリティの要件)  8.5 ALCOA+CCEA  8.6 メタデータ  8.7 監査証跡(Audit Trail)  8.8 データインテグリティの発端事件  8.9 FDAの Warning Letterの例など   8.10 データインテグリティのまとめ 9.QC/QA実施のポイントと、見過ごされやすい問題事例の紹介  9.1 QC実施のポイント   9.1.1 どこでミスしやすいか   9.1.2 根拠資料がない!   9.1.3 生データにおける指摘   9.1.4 再測定、不採用データ   9.1.5 機器管理における指摘   9.1.6 試料管理における指摘   9.1.7 その他の指摘  9.2 定量試験、定性試験の共通事項  9.3 定量試験  9.4 構造決定試験での留意点  9.5 QCとQAの違いについて 注意事項 納品後のキャンセルはお受けできませんので予めご了承ください。イーコンプレスVOD配信セミナー セミナー映像・資料はDVDで納品 自主学習・企業内でのグループ研修におすすめ 新人社員研修などに最適 地方や自宅(テレワーク)でも受講できる
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页面Trace信息
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[ 25-07-19 20:10:33 ] RunTime:0.000288s SQL = SELECT * FROM bio_agent WHERE ( `isViews` = 1 ) AND ( `domain` LIKE '%test.ripai.com' )
[ 25-07-19 20:10:33 ] RunTime:0.000208s SQL = SELECT * FROM bio_agent WHERE ( `domain` = 'www.jp-daigou.com' )
[ 25-07-19 20:10:33 ] RunTime:0.000293s SQL = select * from bio_siteparams where FIND_IN_SET('081',AgentID)
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[ 25-07-19 20:10:33 ] RunTime:0.000359s SQL = SHOW COLUMNS FROM bio_syscolumn
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错误记录 : 100条错误
[ 25-07-19 20:10:33 ] 注意:[8] A session had already been started - ignoring session_start() App.class.php 第 115 行.
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[ 25-07-19 20:10:33 ] 注意:[2048] Redefining already defined constructor for class XML_Parser Parser.php 第 206 行.
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[ 25-07-19 20:10:33 ] 注意:[8] Undefined index: openid BaseAction.class.php 第 72 行.
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[ 25-07-19 20:10:33 ] 注意:[8192] Assigning the return value of new by reference is deprecated Client.php 第 179 行.
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[ 25-07-19 20:10:33 ] 注意:[2] shuffle() expects parameter 1 to be array, boolean given BaseAction.class.php 第 418 行.
[ 25-07-19 20:10:33 ] 注意:[8] Undefined property: RakutenApiExecuter::$ApiDataWorker RakutenApiExecuter.php 第 346 行.
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[ 25-07-19 20:10:33 ] 注意:[2048] Non-static method PEAR::isError() should not be called statically, assuming $this from incompatible context getApiData.php 第 503 行.
[ 25-07-19 20:10:33 ] 注意:[2048] Non-static method PEAR::isError() should not be called statically, assuming $this from incompatible context getApiData.php 第 509 行.
[ 25-07-19 20:10:33 ] 注意:[2048] Non-static method PEAR::isError() should not be called statically, assuming $this from incompatible context RakutenAction.class.php 第 595 行.
[ 25-07-19 20:10:33 ] 注意:[8] Undefined index: isDebugMe RakutenAction.class.php 第 607 行.
[ 25-07-19 20:10:33 ] 注意:[8] Undefined index: categoryPath RakutenCategoryGetter.class.php 第 55 行.
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[ 25-07-19 20:10:33 ] 注意:[8] Undefined index: descpre RakutenAction.class.php 第 645 行.
[ 25-07-19 20:10:33 ] 注意:[8] Undefined variable: type_ BaseAction.class.php 第 649 行.
[ 25-07-19 20:10:33 ] 注意:[8] Undefined variable: agentId common_inc.php 第 3135 行.
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[ 25-07-19 20:10:33 ] 注意:[8] Undefined index: store 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 486 行.
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