The Ministry of industry and trade of the Russian Federation
FSI «SID & GP»
+7 (495) 676-43-60 109044, Moscow, Lavrov lane., 6

Elena Perezhogina

Elena Perezhogina
Lead Specialist in the Evaluation Unit at the FSI “SID & GP”

Twenty-five years of professional experience.

Education: Leningrad ChemicalPharmaceutical Institute (higher education diploma). Major: Chemical technology of biologically active compounds,

Qualification: Chemical Process Engineer. Advanced training in quality assurance of pharmaceutical production. Advanced training in GMP inspections/audit.

Professional experience: from 1987 to 2016 worked as a Process Engineer of injection drugs, Principal Manufacturing Engineer in the Production Department of finished dosage forms, Senior GMP Technologist , Senior Engineer in the Office of QA Documentation Development, Deputy QA Supervisor  / Senior Auditor,  Quality Assurance Supervisor, Certification and Licensing Manager, Qualified Person for products release, acting Quality Head. In February 2017 joined the Evaluation Unit at the FSI “SID & GP” as a Senior Specialist. As of September 2017 her professional portfolio also includes teaching in the Training and Methodological Department of the Educational Centre for Good Practices.

 

Teaching activities: GMP requirements for documentation in pharmaceutical manufacturing, Batch Production Records. Requirements, structure, rules of processing and archiving, organization of self-inspections at pharmaceutical companies.