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
E-mail: ekaterina.ryzhikova@sbmrussia.com
Phone: +7 (915) 455-65-78
Other materials
- FSI “SID & GP” and CDSCO, India signed a cooperation agreement.
- The importance of reference samples in the development of pharmaceutical industry was discussed during the meeting of the Healthcare Commission of the General Council of the UNITED RUSSIA Party
- The program of the IX All-Russian GMP Conference with international participation has been published
- Attendees of the ‘Ensuring Drug Security’ Forum discussed issues of public trust in the Russian pharmaceutical products
- Vladislav Shestakov took part in the 8th International Pharmaceutical Congress Russia – Nicaragua “Evolution of Production Potential: Localization of Production to Strengthen the International Health Care System”
