February 1 – 2, 2017 workshop “Quality risk management for GMP and pharmaceutical development”
On February 1 – 2, 2017, the State Institute of Drugs and Good Practices of the Russian Ministry of Industry and Trade will conduct a workshop dedicated to “Risk Management for GMP Quality and Pharmaceutical Development”.
The workshop will address risk management issues to ensure quality standards as regulated by good manufacturing practice rules. Participants will have a unique opportunity to receive answers to topical questions directly from experts of the Ministry of Industry and Trade and SID & GP.
We will discuss in detail methods of quality risk management. Participants will review quality risk management at the stages of drugs development, introduction, and production. The students will solidify theoretical knowledge during practical part of the seminar. Our experts will touch on new regulatory requirements for work with claims, replacement requests and complaints, as well as organization and conduct of recall of drugs.
You will study assessment of the risk profile of an excipient and its manufacturer, will understand what “appropriate” GMP requirements mean in relation to excipient manufacturers, as well as who and how establish these requirements and oversee their implementation. A practical lesson on the topic will be held, the results of which can be used in internal procedures of the company’s quality system.
In the workshop we will analyze major inconsistencies revealed during GMP-inspections both in Russia and abroad. Will review risk-oriented planning of inspections and audits, their organization and conduct.
The workshop will be led by Professor Yuri Vasilyevich Podpruzhnikov Pharm.D, certified EU expert, auditor, teacher of GMP and GDP.
Students who will confirm their skills will receive personal certificates.
Location: Moscow, Bryusov per.2 / 14, p. 8.
Contact person: Ekaterina Ryzhikova
Phone: +7 (915) 455-65-78
- Good practices in drug quality assurance from development to the consumer
- GMP inspectorates of Russia and Uzbekistan signed an Agreement on Cooperation
- Typical PQS deficiencies found at drug manufacturers: what does a GMP inspection focus on?
- The Russian and the Chinese GMP inspectorates discussed the prospects for cooperation
- SID & GP together with the Pirogov Russian National Research Medical University (RNRMU) have taken up development of drugs for children