Seminar 27-28 September 2017 «Pharmaceutical quality system. Documentation principles. Assessment of Suppliers
FSI «State Institute of Drugs and Good Practices» of the Ministry of Industry and Trade of the Russian Federation conducts the educational seminar «Pharmaceutical quality system. Documentation principles. Assessment of Suppliers» (18 academic hours).
The Seminar will cover the following topics:
Day 1, 27 September 2017
- Pharmaceutical quality system in the framework of ICH Q10 document requirements.
- GMP requirements to documentation in pharmaceutical production.
- Dossier on series. Requirements, structure, communication and archiving rules.
- Approaches to the organization of technology transfer.
Day 2, 28 September 2017
- Organization of self-inspection process at a pharmaceutical enterprise.
- Work with claims and production recalls.
- Contractual work (outsourcing).
- Evaluation and assessment of suppliers and contract executors, conducting audits.
Seminar is conducted by:
Perezhogina Elena Anatolievna, Leading Specialist of the Second category of the Expertise Department, FSI «SID & GP»;
Zhilin Aleksey Vladimirovich, Leading Specialist of the Medicines production inspection Department, FSI «SID & GP»;
Smirnov Vladimir Alekseevich, Leading Specialist of the Medicines production inspection Department, FSI «SID & GP».
Venue: to be confirmed
Contact person: Ekaterina Ryzhikova
Phone: +7 (915) 455-65-78
- Working trip of the FSI “SID & GP” employees together with the Ministry of Industry and Trade of Russia
- The delegation of the FSI “SID & GP” took part in the conference “India Pharma 2018”
- Voting for the best symbol of GMP-conference is opened
- Interview on a stage with Vladislav Shestakov
- Presentation at the 1st All-Russian Scientific and Educational Congress with international participation “Oncoradiology, Radiodiagnosis and Therapy”