2020.02.23 EUにおける医療機器規制(MDR/IVDR) Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a 'person responsible for regulatory compliance'(PRRC)
FDA 2018.12.23 Guidance for Industry Process Validation: General Principles and Practices (2011.1) COPY TITLE&URL Guidance for Industry Process Validation: General Principles and Practices (2011.1) ]]> Tweet Share Hatena Pocket RSS feedly Pin it 医薬品品質システムに関するガイドラインについて(平成22年2月19日、薬食審査発0219第1号、薬食監麻発0219第1号) Previous post FDA査察対応結果 Next post
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