1. 要求事項
2. リスクマネジメント概要
1. リスクマネジメントとは
2. リスクマネジメントとリスク分析の違い
3. リスクマネジメント
1. 意図する使用及び合理的に予見可能な誤使用
2. 安全に関する特質の明確化
3. ハザードの特定及び危険状態に至る一連の事象の特定
4. リスクの推定
5. リスクコントロール
6. 残存リスクの評価
7. リスクマネジメント報告書作成
8. 製造工程のリスクマネジメント
9. 製造及び市場出荷後の情報のレビュー
4. ユーザビリティエンジニア概要
1. ユーザビリティとは
2. ユーザビリティは使いやすさの評価とは違う
5. ユーザビリティエンジニア
1. 使用関連仕様の作成
2. 安全に関連するユーザーインターフェイス特性の特定
3. 既知の又は予見可能なハザード及び危険状態の特定
4. ハザード関連仕様シナリオの特定及び記述
5. 総括的評価のための使用シナリオの選択
6. ユーザーインターフェイス仕様の確立
7. 形成的評価の実施
8. 総括的評価の実施
9. 開発過程が不明なユーザーインターフェイス(UOUP)の評価
10. ユーザビリティエンジニアリングファイル
11. リスクマネジメントとユーザビリティの関係
【講師】 居原 範道 氏(QMサービス.IHARA)
医療機器の品質システム(QMS)構築・改善、手順書作成ならびに監査サポートに関する個人コンサルタント、製造販売業許可申請、製造業登録申請サポート等を主な業とする個人コンサルタントを千葉県で開業するとともに医薬品、医療機器コンサルタント会社と提携を結ぶ。
現在は個人および提携コンサルタントとして業務中。
【主な略歴】 外資大手医療機器企業にて製造技術開発業務を担当。
透析液の滅菌方法の検討とその分解物生成への影響の評価を行なった後、新滅菌方法と新薬の日本市場導入、ディスポ― ザル透析液バッグとその部品開発などを担当する。
その後、外資系大手製薬企業において、品質保証部部長を務める。
輸入医薬品・医療用具の品質保証、品質管理、品質システムコンプライアンス、苦情処理の4つのグループのマネジメントを担当する。
また品質システム統合プロジェクトマネジャーとして、医療機器のGQP,GVP,QMS 各システムの統合/再構築、国内製造所の医療機器包装等製造業許可取得、東京都庁査察対応等の業務を行う。
2008年、外資系大手医療機器企業において、高度管理医療機器製造販売業 品質保証責任者兼、品質保証部シニアマネジャーを務める。 2015年6月から現職。
関連商品
[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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