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:
Senior project manager
+7 (916) 673-6965
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- 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