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 Cooperation Agreement was signed between State Institute of Drugs and Good Practices and National agency of pharmaceutical products of Algeria
- SID&GP passed the recertification audit of the Quality Management System according to ISO 9001:2015
- Russian Federation has submitted an application for the Pharmaceutical Inspection Co-operation Scheme PIC/S accession
- SID&GP experts participated in the ISPE Eurasian Affiliate pre-conference
- Signing of Cooperation agreement between FSI “SID&GP” and Agency for medicinal products and medical devices of Bosnia and Herzegovina