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.
- The traditional workshop at the GMP Conference to be held as a game-based quest
- Revised Guidelines on Data Integrity and Validation of Computerised Systems
- Experience of Independent Examination in Pharmaceutical Manufacturing
- Vladislav Shestakov: “Time not to contemplate, but to act!”
- The third GLP-PLANET Conference to take place in St. Petersburg