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 CDER「Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers」
FDA Plans to Issue Part 11 Q&A Guidance
FDA U.S. inspections resumed
When is a manufacturing and marketing license required to be obtained?
Manufacturing and Quality Control Systems at Pharmaceutical Manufacturers
Three requirements for authenticity
Differences in regulatory requirements between Europe, the U.S. and Japan
Is verification unnecessary with validation?