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Corso chfg
Good manufacturing practice in a hospital laboratory
(SVB0213)
Teacher:
Katia Mareschi
Year:
2nd year
Degree course:
Cellular and Molecular Biology
MATERIALE DIDATTICO
AA 2020/2021
Articles
Comparison of regulatory pathways for the approval od advances therapy in the European Union and United states
EU regulatory Patwahys for ATMP review
Risk assessment approach to microbiological controls of cell therapy
Exercises
CIK production process Flowchart
CIK production standard operative procedure
Risk management in CIK pruduction process
Other files
Reflection paper on classification of advanced therapy medicinal products
Slide
Behavior and sanification in cell factory
Documentation
Dressing in class B
Dressing in class d/c
Introduction to the GMP
Laboratory Quality Management
Premises and equipments in cell factory
Qualification of operators
regulatory pathway of an ATMP
risk management
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