Seiichi Hata
Clinical Quality Audit & Assurance Professional
畑 誠一
臨床監査・信頼性保証コンサルタント
Contact via e-mail: s.hata.gcp@icoud.com
Contact via phone: +81-(0)90-4208-7875
Contact via LinkedIn: Seiichi Hata | LinkedIn
Contact via the consulting company (Adamas, InClin, Apotech, TMC Pharma, etc.)
Summary
- Pharmacist, M. Pharm. Sci
- 24 years in Pfizer, 4 years in CROs, 2 years in BI since 1 APR 1985
- More than 33 years’ GCP QA experience since 1 Apr 1985
- Independent CQAA since 1 Sep 2015
a. GCP investigator site audits, vendor audits, Clinical Lab Audits, Deveopment Partner Audit, Internal System Audit and CSV audits
b. PMS, PV, RWD vendor audits
c. Two PMDA mock inspections in USA in 2019, a PMDA Mock Inspection in Korea in 2023 and PMDA inspection supports in Japan in 2018, 2020, 2024 and 2025
d. EMA inspection support in Japan in 2018 and FDA inspection support in Japan in 2024
Curriculum Vitae
My Favorite
I have been sixty-agers and a happy grandfather of the first granddaughter since 2020. She is really powerful girl, and we often play together with toys.
The second granddaughter was born in 2024.
Absolutely she is cute like an angel
The third granddaughter was born in 2025.
Absolutely she is cute like an angel.
I love them very much, and I will be a grandfather and the stepladder for them.
