PIC/S GMP Annex 11 Computerized System Revision
【medical equipment】Risk Management Course Part 1.
From QSR to QMSR
FDA CSA Draft Guidance with Bilingual Translation
[Preliminary] FDA’s Draft CSA Guidance Issued on September 13, 2022.
Importance of the skill map
Quality culture and Data integrity
【translation into Japanese】FDA Part 820 QMSR(Quality Management System Regulation)revised plan
FDA Publishes Proposed Revisions to QSRs