SooYoung Kwak·Mar 3, 2024AIRIS 2024 참석 후기2024.2.26 ~ 2.29까지 서울 신라호텔에서 식약처와 미국 FDA 공동으로 AIRIS (AI Regulatory & International Symposium) 2024 심포지엄이 “Use of AI in Medical Product…
Helloqualitytribe·Mar 7, 2023Best Practices for Regulation, Compliance and change Management.Below are a few best practices for running a rugged and efficient change-control framework.
Helloqualitytribe·Mar 5, 2023Managing Deviations and CAPA: Faults in investigation and Deviation management.Deviations and CAPA stay as an intriguing issue in regulatory inspections. Data regarding previous regulatory inspections reveals that…
Helloqualitytribe·Jan 25, 2023Important Questions and Answers concerning the Audit Trail Review — Part 41. May we define entries in our CDS such as standard concentrations, densities, dilution factors, hence parameters used for the…
InLunit Team BlogbySooYoung Kwak·Jul 20, 2020US FDA Regulation 관련 링크미국 FDA의 규제 절차 및 허가 신청과 관련된 링크 모음입니다.
