Tenders Are Invited For Training Of Gmp, Gcp And Glp Inspectorate Employees

Validation Of The Production Of Purified Water And Water For Injection (Strategy, Validation Phases, Determination Of The Duration Of Phases And Sampling Points, Development Of Specifications For Water At Various Stages Of Its Production (After Softening, Pre-Filtration, Reverse Osmosis, Etc.), Validation Acceptance Criteria) (20 People), Process Validation, Assessment, Process Suitability And Reproducibility Indices (Ppk, Cp, Cpk, Etc.) (20 People), Requirements For The Production Of Sterile Medicinal Products (Clean Rooms And Cleanliness Classes (Frequency Of Confirmation And Testing, Environmental Monitoring), Isolation Technologies And Rabs Systems, Engineering Systems (Hvac System, Compressed Air, Inert Gases And Water Treatment System (Water For Injection, Purified Water) For Sterile Production) (20 People), Risk-Based Approach To Organizing Inspections. Risk Assessment (20 People), Gcp Inspection Of Clinical Trials Of Medicines And Medical Devices: International Standards And Regulatory Framework Of The Eaeu.Inspection Of Drug Studies. Inspection Of Research/Testing Of Medical Devices (20 People)