Yukimitsu Yamagishi

Position

Managing Consultant

Specialized field

Pharmaceutical Industry, IT strategy

【Major responsible areas】
· IT system conversion support in the CMC division of the pharmaceutical industry
(Deviation management, change management, CAPA, SOP management, manufacturing plan management,
Test operation management, drawing management, equipment management, planning and report management)
· Support for building event tracking system based on TrackWise for pharmaceutical factory, Pharmaceutical QA department
· Support for building a document management system for DMF for overseas manufacturing in the drug substance manufacturing industry
· ER / ES policy for pharmaceutical industry and support for formulating guidelines
· Support for preparing CSV document at IT system construction in the pharmaceutical industry
 
[Writing paper etc]
· Points of compliance with ER / ES regulation in eCTD creation
("Bible for Successful Writing of Pharmaceutical Affairs Application to the World" published by Technical Information Association 2012/12/28)
(http://www.gijutu.co.jp/doc/b_1702.htm)
· Risk assessment of computerized systems in clinical trials (co-authored with Ken Yoshimura)
("Computerized system proper management compliance practice and document preparation example case" published by Technical Information Association 2013/3/31)
(http://www.gijutu.co.jp/doc/b_1713.htm)
· Approach of validation of existing system (co-authored with Ken Yoshimura)
(Publication of information system 2013/6/30 "How to advance electronicization and CSV compliance in clinical development")
(http://www.johokiko.co.jp/publishing/BA130606.php)