Workshop “Organization of a quality control system in pharmaceutical production in accordance with GMP requirements”; “Validation and transfer of analytical methods”
We are happy to invite you to become part of the workshop dedicated to ‘Organization of a quality control system in pharmaceutical production in accordance with GMP requirements’; ‘Validation and transfer of analytical methods’. The event is scheduled for march 21, 2018 and will last 8 academic hours.
We will cover the following issues during the workshop:
I ORGANIZATION OF A QUALITY CONTROL SYSTEM IN PHARMACEUTICAL PRODUCTION IN ACCORDANCE WITH GMP REQUIREMENTS
1. Organization of the quality control department – structure, principles, general requirements.
2. Documentation circulating in the quality control department.
3. Organization of sampling.
4. Conducting tests
5. Study of stability in drugs
6. Ensuring the integrity of QC data (based on the example of chromatographic analysis).
7. Examples of deviations most frequently detected during inspection of pharmaceutical production. Analysis and possible ways of prevention.
II VALIDATION AND TRANSFER OF ANALYTICAL METHODS
1 Terms and definitions: validation, verification, transfer of analytical methods.
2 General requirements for validation methods.
3 Validation parameters of analytical methods.
4 Organization of analytical methods transfer.
5 Examples of deviations most frequently detected during inspection of pharmaceutical production. Analysis and possible ways of prevention.
The workshop will be conducted by:
Ivan GULYAEV – Chief Specialist, Dept. of pharmaceutical Production Inspections FSI ‘SID&GP’
Participation fee is 20500 roubles per person.
Please do not hesitate to contact:
Ekaterina Ryzhikova
Senior project manager
+7 (916) 673-6965
Ekaterina.Ryzhikova@sbmrussia.com
Other materials
- Vladislav Shestakov took part in the BioHabana 2024 Congress
- Registration for GMP Conference 2024 is now open
- Cooperation issues in the pharmaceutical industry and healthcare system were discussed at the Russia-Africa Summit
- International cooperation discussed at the Drug Safety Forum
- Transformation of medical education and training of highly qualified personnel discussed at the Uzbek-Russian Medical Forum