Seminar 10.10.2017 «Theory and Practice of Inspection and Audit conduct on compliance with GMP requirements. Approaches, methods, methodology and rules for conducting of local and foreign production sites»
FSI «State Institute of Drugs and Good Practices» of the Ministry of Industry and Trade of the Russian Federation conducts the Educational Seminar «Theory and Practice of Inspection and Audit conduct on compliance with GMP requirements. Approaches, methods, methodology and rules for conducting of local and foreign production sites». 9 academic hours.
The Seminar will cover the following topics:
- Legal regulations concerning the inspection of local and foreign manufacturers of medicines to meet the requirements of Good Manufacturing Practice.
- Basic principles and procedures for conducting inspections of local manufacturers (under licensing control) and foreign medicines manufacturers.
- Key issues of preparing local pharmaceutical manufacturers for licensing inspections.
- Organization of reception and support of inspection commissions at foreign production sites.
- Methodology for conducting inspections and audits: rules of conduct, organizational aspects, mistakes and obstacles.
- Good practice of preparing corrective and preventive action plans upon the results of the inspection/audit.
Seminar is conducted by:
Orlov Vladimir Alexandrovich — Deputy Head of the Educational Centre of FSI «SID and GP»
A representative of the Department for Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation.
The detailed program of the Seminar is at the following web-site: https://gilsinp.ru/
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