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

1. Pharmaceutical quality system in the framework of ICH Q10 document requirements.
2. GMP requirements to documentation in pharmaceutical production.
3. Dossier on series. Requirements, structure, communication and archiving rules.
4. Approaches to the organization of technology transfer.

Day 2, 28 September 2017

1. Organization of self-inspection process at a pharmaceutical enterprise.
2. Work with claims and production recalls.
3. Contractual work (outsourcing).
4. 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

E-mail: ekaterina.ryzhikova@sbmrussia.com

Phone: +7 (915) 455-65-78