(全16講)医療機器QMS規制要件セミナー【第2講】規制要件概要

医療機器企業に初めて入社・転職した人向けの規制要件入門コースです。QMSを中心に解説を行います。

本邦では、医療機器企業(製造販売業)においては、QMS省令(体制省令)およびGVP省令に則った体制の構築が出来ていなければなりません。
またQMS省令に従って、QMS(Quality Management System:品質管理システム)が文書化されており、適切にQMSに従って運用されており、それら活動の記録が作成されていなければなりません。
QMS省令は、ISO 13485をもとに作成されています。
ISO 13485は、マネジメント(経営者)の責任・リソース(資源)の配分(Plan)、製品実現(Do)、監視測定(Check)、改善(Action)といったPDCAサイクルで構成されています。
PDCAサイクルがあるということは、品質保証システムがあるということで、「今日」よりも「明日」、「明日」よりも「明後日」の方が品質が向上していくという証明となります。 規制当局は「継続的な改善」を求めています。 日進月歩の医療機器においては、常に設計変更が求められ、品質の改善も求められています。

本講座は16講(2時間/講)にわたって、医療機器業界にけるQMSに関する規制要件の内容を初心者にとって分かりやすく、丁寧に解説いたします。

【講演内容】
【第1講】 入門医療機器業界
【第2講】 規制要件概要
【第3講】 用語の定義
【第4講】 品質システム
【第5講】 経営者の責任
【第6講】 資源の運用管理
【第7講】 設計管理
【第8講】 リスクマネジメント
【第9講】 ソフトウェア開発
【第10講】 製造及びサービスの提供
【第11講】 購買管理
【第12講】 苦情管理
【第13講】 内部監査
【第14講】 不適合製品の管理
【第15講】 データ分析
【第16講】 CAPA

お役立ち動画

https://www.youtube.com/watch?v=BfbyfBs4x28

(全16講)医療機器QMS規制要件セミナー

【第1講】入門医療機器業界  【第2講】規制要件概要

関連商品

[blogcard url=”https://ecompliance.co.jp/SHOP/QMS-LIVE.html” title=”(全16講)医療機器QMS規制入門セミナー【一括受講コース】” content=”医療機器企業に初めて入社・転職した人向けの規制要件入門コースです。QMSを中心に解説を行います。

本邦では、医療機器企業(製造販売業)においては、QMS省令(体制省令)およびGVP省令に則った体制の構築が出来ていなければなりません。
またQMS省令に従って、QMS(Quality Management System:品質管理システム)が文書化されており、適切にQMSに従って運用されており、それら活動の記録が作成されていなければなりません。
QMS省令は、ISO 13485をもとに作成されています。
ISO 13485は、マネジメント(経営者)の責任・リソース(資源)の配分(Plan)、製品実現(Do)、監視測定(Check)、改善(Action)といったPDCAサイクルで構成されています。
PDCAサイクルがあるということは、品質保証システムがあるということで、「今日」よりも「明日」、「明日」よりも「明後日」の方が品質が向上していくという証明となります。
規制当局は「継続的な改善」を求めています。
日進月歩の医療機器においては、常に設計変更が求められ、品質の改善も求められています。

本講座は16講(2時間/講)にわたって、医療機器業界にけるQMSに関する規制要件の内容を初心者にとって分かりやすく、丁寧に解説いたします。”]

[blogcard url=”https://ecompliance.co.jp/processdocument/ISO-13485%EF%BC%9A2016.html” title=”【ISO-13485:2016対応 QMSひな形】” content=”ISO-13485:2016に沿った形の各ひな形です。”]

[blogcard url=”https://ecompliance.co.jp/processdocument/FDA%20CFR%20820%20QSR.html” title=”【FDA CFR 820 QSR対応 QMSひな形】” content=”FDA CFR 820 QSR対応 QMSひな形”]

[blogcard url=https://xn--2lwu4a.jp/qms-md/ title=”QMS(手順書)ひな形 医療機器関連” ]

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