- The structure and organization of a pharmaceutical industry: functions and responsibilities.
- Quality, Qualification and Validation Concepts. "Technology transfer" concept
- Plants and machinery of the pharmaceutical industry and their construction materials and control
devices for the production of various pharmaceutical forms, with particular reference to: autoclaves;
freeze dryers; fermenters. Furthermore, at the level of centralized or particular lines: steam
generators; distillers; extraction plants, machines for the production of cold.
- C.I.P./S.I.P. Devices
- Work environments: white areas and sterile areas. "Clean-rooms", their use and procedures of use,
construction aspects and materials used. Thermo-hygrometric requirements and particle contamination.
Classification of areas and international regulations. H.E.P.A. Filters and machinery H.V.A.C.
- Production lines - Work areas, floor plans and lay-outs for sterile and non-sterile production:
Area layouts, study of layouts and flows relating to personnel, raw materials, finished products and
packaging materials. Arrangement of work areas and buildings according to "cross-contamination" and
"self-containment" areas. Organization of the warehouse and the training center for lots. Performance
of operating flows.
- Industrial production of radiopharmaceuticals and general considerations on the nature of
radiation. Examples of products on the market for diagnostic and therapeutic use. PET and SPECT,
types of radiopharmaceuticals used, structures for containment, storage, processing.
- Industrial production of Monoclonal Antibodies, large scale production through fermenters,
industrial purification techniques. Examples of products on the market.
The risk under Legislative Decree 81/2008 and subsequent amendments and additions. Collective
prevention and protection measures to protect workers from infectious agents. Personal protective
- Low environmental impact and "energy saving" processes in production plants.