FSI «SID & GP» is holding a training workshop with international participation for pharmaceutical inspectors
From 12 to 14 February, 2019, the State Institute of Drugs and Good Practices together with the FEDEGARI and the NoDeviation companies will hold a training workshop for pharmaceutical inspectors.
The main topics of the workshop to be held will be as follows:
- An overview of the key principles of the ICH Q12 guideline (Drug Product Lifecycle Management);
- Modern approaches to process validation with application of the QbD (Quality by Design), Continuous Process Verification and Ongoing Process Verification principles;
- Industrial methods of thermal sterilization: equipment and sterilization process validation;
- Current methods of industrial decontamination in pharmaceutical manufacture;
- Sterility assurance criteria.
The goal of the workshop is to present the most advanced knowledge and experience possessed by the designers and manufacturers of state-of-the-art pharmaceutical equipment (FEDEGARI) directly supported by international experts in pharmaceutical quality management (NoDeviation) to pharmaceutical inspectors.
- 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