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日本代购-GMP/バリデーション入門
  • ecompliance:10000017
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日本代购-講師 GMPコンサルタント 江口 眞(えぐち まこと) 氏 総収録時間 297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10月27日 内容情報 GMPバリデーション入門-1 * GMPで求められることとは? * なぜ、GMPが必要か?    - GMPが必要な理由    - 品質確保のためすべきこと    - GMPの書類体系    - 省令の位置づけ    - 関連法令 * バリデーション作業が必要とされている背景 * バリデーションの種類    - いつバリデーションを実施するのか? * GEPとGMP * バリデーションへの取り組み * バリデーションの文書化 ------------------------------------------------------------ GMPバリデーション入門-2                                                                               * バリデーション実施の流れ    - プロジェクトの基本計画・基本設計    - エンジニアリングとクオリフィケーション 1. プロセスバリデーション   (1)予測的バリデーション   (2)コンカレントバリデーション   (3)バリデーションマスタープラン 2. 再バリデーション 3. バリデーション実施手順例 4. 必要書類の解説及び具体的な事例    - URS/FAT/SAT/DQ/IQ/OQ/PQ/ ------------------------------------------------------------ GMPバリデーション入門-3 5. キャリブレーション                                                                         (1)キャリブレーションの定義                 (2)キャリブレーション実施方法   (3)キャリブレーションの精度   (4)キャリブレーション実施時期   (5)キャリブレーション実施手順 ------------------------------------------------------------ GMPバリデーション入門-4                                                                              6. 洗浄バリデーション   (1)洗浄バリデーションの目的   (2)洗浄バリデーションの範囲   (3)洗浄バリデーションをいつ実施する   (4)洗浄バリデーションのポイント   1. グルーピング   2. ワーストケース   3. 許容残留値の設定   3-1. 0.1%法   3-2. 10ppm法   3-3. 目視100μg法   3-4. ADI法   3-5. ADE法   3-6. 検出限界以下   (5)サンプリング方法の選定   (6)分析方法   (7)洗浄バリデーションプロセス   (8)まとめ ------------------------------------------------------------ GMPバリデーション入門-5                                                                               7. 空調システムのバリデーション    - URS/DQ/IQ/OQ/PQの具体的な実施方法 8. 包装工程のバリデーション   (1)重要工程例   (2)包装工程のバリデーション例        URS/DQ//FAT/SAT/IQ/OQ *インパクトアセスメント事例 *FAT/SAT/IQ/OQ: 大森機械工業の事例 ------------------------------------------------------------ GMPバリデーション入門-6 9. バリデーションの考え方とその実際について                                                                  (1)バリデーション実務のポイント   (2)GMPバリデーションの考え方                                              (3)製造支援システムのバリデーション   (4)バリデーション実施例 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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[ 25-07-20 00:37:09 ] RunTime:0.000264s SQL = select * from bio_siteparams where FIND_IN_SET('081',AgentID)
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[ 25-07-20 00:37:09 ] 注意:[8] Undefined index: openid BaseAction.class.php 第 72 行.
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[ 25-07-20 00:37:09 ] 注意:[8192] Assigning the return value of new by reference is deprecated Client.php 第 179 行.
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[ 25-07-20 00:37:09 ] 注意:[8] Undefined variable: type_ BaseAction.class.php 第 649 行.
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[ 25-07-20 00:37:09 ] 注意:[2] shuffle() expects parameter 1 to be array, boolean given BaseAction.class.php 第 418 行.
[ 25-07-20 00:37:09 ] 注意:[8] Undefined property: RakutenApiExecuter::$ApiDataWorker RakutenApiExecuter.php 第 346 行.
[ 25-07-20 00:37:09 ] 注意:[8] Undefined index: appid getApiData.php 第 417 行.
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[ 25-07-20 00:37:10 ] 注意:[2048] Non-static method PEAR::isError() should not be called statically, assuming $this from incompatible context getApiData.php 第 503 行.
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[ 25-07-20 00:37:10 ] 注意:[8] Undefined index: descpre RakutenAction.class.php 第 645 行.
[ 25-07-20 00:37:10 ] 注意:[8] Undefined variable: type_ BaseAction.class.php 第 649 行.
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[ 25-07-20 00:37:10 ] 注意:[8] Undefined index: store 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 486 行.
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[ 25-07-20 00:37:10 ] 注意:[8] Undefined offset: 0 ThinkTemplate.class.php 第 578 行.
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