A seminar on the topical issues in the field of inspection was held by the FSI «SID&GP» Educational Center
On June 13-14, 2017, a two-day seminar on the topic «Organization, preparation and implementation of inspections. Manufacturer’s and applicant’s responsibilities and accountability. Analysis of the most common discrepancies identified during inspection» took place in Moscow. It was attended by about fifty employees of several.
Leading pharmaceutical companies.
The seminar was organized by the State Institute of Drugs and Good Practices (SID&GP). The main objective of the event was to share information concerning subtle aspects of preparing for and conducting inspections, proper documentation and deadlines along with essential observations made by inspecting officers. In other words, everything that manufacturers who make preparations for an upcoming inspection should know.
The following subjects were covered in detail during the seminar: matters on different stages of preparation for an inspection; proper documentation handling (preparation, deadlines, volume and scope, cover letters); major issues and discrepancies, an applicant’s course of action on a manufacturing site, main groups of discrepancies, analysis, various preventive and corrective measures.
SID&GP employees, namely the Head of the Examination Department Madina Sottayeva, the Head of the Inspection of Drug Manufacturing Department Natalia Chadova, the Deputy Head of the Inspection Department Vladimir Orlov and the lead specialist Nadezhda Arkhipova conducted the seminar.
Please explore the photo report of the event provided below:
- What is in the Programme of V GMP-conference?
- The rules of organizing and conducting inspections of drug manufacturers for the compliance with GMP requirements have been changed
- FSI “SID & GP” of the Ministry of Industry and Trade of the Russian Federation and company Sandoz held the first online forum on biotechnologies
- The SID&GP under the auspices of the Ministry of Industry and Trade of the Russian Federation conducted the first online inspection of Roche’s manufacturing site
- Rules for organizing and conducting inspection of pharmaceutical manufacturers for compliance with GMP requirements have been changed