Considering the importance of passing the inspection and third-party audit, training on how to conduct and pass audits, as well as on proper organization of the company's internal self-inspections is undoubtedly needed.
In order to become a good auditor and audited, theoretical training and practical skills are equally required. It is not only the knowledge of the technical aspects, but also practical communication skills, the capability to ask questions, listen to the answers, and give correct answers on the raised questions.
In this regard, we provide training for:
Also, we provide training for internal auditors of pharmaceutical producers.
1. GMP. Qualified Person of pharmaceutical company. Basic requirements and functions (training workshop).
2. Quality Risk Management – system of risk management in pharmaceutical company in accordance with the GMP requirements and the provisions of the PQS (seminar).
3. Basic provisions of the rules of due manufacturing of pharmaceutical products (short GMP fundamentals course) (training workshop).
4. Basic provisions of the rules of due distribution of medicines (short basic GDP course) (training workshop).
5. The basic requirements for the production of sterile pharmaceutical products as part of updated GMP rules. Production in aseptic conditions (training workshop).
6. Validation and qualification of the pharmaceutical company under the requirements of GMP and internationally recognized standards. The interpretation of the requirements of the regulatory authorities, their expectations and evaluation during the inspection (seminar).
7. Validation of pharmaceutical production (training workshop).
8. Site Master File – basic requirements and practice of its drafting (training workshop).
9. Key personnel. Qualified Person - main function and key responsibilities in accordance with the GMP requirements and the provisions of the PQS. Institution of Qualified persons. Requirements to Qualified persons (training workshop).
10. Materials and packaging processes of pharmaceutical products: requirements, basic procedures and measures to minimize the risks of release of nonconforming production, (seminar).
11. Proper system of personnel staff in pharmaceutical company and practical issues of implementation of GMP requirements for the personnel system: organization, qualification, hygiene, education, medical examinations, proper handling of technological clothing (seminar).
12. Proper handling of pharmaceutical products in the warehouse - some of the procedures in accordance with updated GDP EU rules and GSP rules: transportation, handling with a potentially nonconforming production (defect, returns, feedbacks, complaints, counterfeits) (training workshop).
13. The proper functioning of the pharmaceutical warehouses, taking into account the requirements of GMP and GSP. The interpretation of the requirements of the internationally recognized regulatory authorities and their expectations during the inspection of pharmaceutical warehouses (seminar).
14. Proper cleaning as a key factor in the safety of pharmaceutical products during their production. Validation of cleaning procedures: basic approaches and practical models (training workshop).
15. Appropriate sampling procedures for quality control (seminar).
16. Ensuring the quality of pharmaceutical products during their wholesale distribution within the GDP / GSP requirements (seminar).
17. The main production documentation in accordance with GMP requirements. Batch Formula. Technological instructions. Batch Record (workshop).
18. The main production documentation: packing instruction / product series packaging protocol. Workshop on drawing up (seminar).
19. Basic GMP regulations (seminar).
20. Design and installation, maintenance of premises, equipment, engineering systems, ensuring proper functioning of the production sites. Basic requirements (training workshop).
21. Contract system (outsourcing), system of external audits of pharmaceutical companies within the PQS. The risk-oriented approach. The interpretation of the requirements of regulatory authorities and their expectations during inspection (training workshop).
22. The system of due manufacturing documentation, practical issues. Proper documentation management system. The main production documentation: Batch Formula, Processing Instruction, Batch Record (training workshop).
23. Pharmaceutical company personnel system under the requirements of GMP (training workshop).
24. The system of premises of pharmaceutical company (main areas, cleanrooms, technical systems): design, installation, preparation for use, qualification, operation. Main methods (training workshop).
25. The quality management system and quality service features at the pharmaceutical company. New components and trends of updated GMP rules (training workshop).
26. The quality management system and quality service features at the pharmaceutical company. New components and trends of updated GMP rules (2nd module), (training workshop).
27. The quality management system at the pharmaceutical company. Tasks and functions of the quality service of pharmaceutical company (QA – quality assurance). Basic requirements in view of last update of GMP rules (training workshop).
28. Quality Risk Management in pharmaceutical company. The risk management strategy, the basic tools and practical models in accordance with the recommendations of the EMA, PIC / S, WHO, ICH (seminar).
29. Quality Risk Management in pharmaceutical company. Risk Management Tactics (seminar).
30. Packaging and labeling of pharmaceutical products – basic GMP requirements and PQS regulations, their implementation and practical models. Risk-based approach. The interpretation of the requirements of regulatory authorities and their expectations during inspection (seminar).
31. Qualified Person in pharmaceutical company. Main function, key responsibilities of Qualified Person in terms of updated GMP EU rules and PQS requirements. Institute of Authorized Persons (training workshop).
32. Pharmaceutical Quality System (PQS) and its key components: Quality Risk Management (QRM) in accordance with the requirements of GMP - basic provisions, practical aspects and implementation models (seminar).
33. Pharmaceutical Quality System (PQS) and its components: system aimed at eliminating deviations, change control, corrective and preventive actions (САРА) (training workshop).
Luzhnetskaya embankment, 6, building 1