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
- The volume of Indian drugs in the Russian market was $770 mln in 2018
- Mr. Vladislav Shestakov called for taking a quantum leap in GLP
- Interaction points were discussed by SID & GP with EDQM
- The inspection of the foreign pharmaceutical company registering its drug product in Kazakhstan was carried out by the Russian Inspectorate
- 157 license holders out of 189 manufacturing sites have received a GMP-certificate following the procedure of filing an application