The Seven Stages of CAPA
PIC/S GMP Annex 16 newly established
Fewer data integrity findings
Determine the root cause
Public comments on proposed amendments to ICH Q9 QRM
品質リスクマネジメントに関するガイドラインの改正（案）に対するパブリックコメントの募集
FDA Plans to Issue Part 11 Q&A Guidance
FDA U.S. inspections resumed
Manufacturing and Quality Control Systems at Pharmaceutical Manufacturers