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
- Workshop “Organization of a quality control system in pharmaceutical production in accordance with GMP requirements”; “Validation and transfer of analytical methods”
- Milan hosted first in history convention of the Russian-Italian subgroup for pharmaceutical industry and medicine
- Working trip of the FSI “SID & GP” employees together with the Ministry of Industry and Trade of Russia
- The delegation of the FSI “SID & GP” took part in the conference “India Pharma 2018”
- Voting for the best symbol of GMP-conference is opened