מערכות האיכות, GMP ורגולוציה

קוד קורס: 50096
3 נ"ז

Reliability and Quality Control; Quality Assurance and Quality Management System; Quality toolbox, measurement and statistics as tools for continual improvement, reduced variation and increased reliability; Reliability – product lifecycle, reliability definition and developing life and reliability testing plans; CPPs vs CQAs as a means to control variability / improve reliability; Acceptance sampling as a quality control tool to design quality into the system; acceptance sampling by attributes. Acceptance sampling systems; Proactive quality control; Data collection methods; Defining parameters and collecting useful information;  Data analysis: statistical process control charts, upper and lower control limits vs specification limits, quality rating system; Reactive, retrospective use of quality tools: the investigation toolbox; brainstorming and risk management and expanding thinking vs focusing and implementing corrective and preventive actions; Reactive retrospective use of quality tools part two: Process validation as a tool for demonstrating reliability; Annual product review / product quality review as a tool for lifecycle control of product reliability ; Review (by students) of what was learned this semester: what is reliability, quality control and tools for process control and feedback; Quality of medicinal products; Legal basis for control of medicinal products in Israel and the world; Quality Management System and SOPs ; Training and Qualification of employees; Quality Control Laboratory as a part of the quality system ; Stability and the shelf life of the medicinal products; Investigation of Deviations from the specifications; Change Controls Management; Principles of facility and equipment planning in the production of medicinal .products; Principles for planning of production and packaging processes in the production of medicinal products

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