Course topics are the organization of the documentation of Quality System, management of personnel training, qualification of suppliers, theory and case studies on the management of changes, deviations, out of specification, claims and appeals, as well as insights on the process batch release and execution of self-inspection.
The course will deal issues such as management of Quality Control equipment (with emphasis on qualification activities, preparation of operating procedures, maintenance plans – Calibration – Revalidation and logbook), the regulatory approach and management of validation protocols for analytical methods and management of technical documentation for Quality Control (eg specifications, laboratory notebooks, etc.). The course will analyze case studies and real life situations.
The course aims to deepen the management of production equipment through the analysis of qualification protocols, preparation of procedures, maintenance plans – Calibration – Revalidation and logbook. The analysis of the management of raw materials and stores, the production flow and batch records and procedures for environmental monitoring will be the topics of this module. The course will analyze case studies and real life situations.
Technical characteristics and principles of operation of the cyclotron and HVAC (Heating, Ventilation, Air Conditioning) and industrial gases will form the basis of the course concerning the activities of the department and cyclotron facilities. Specifically, it will cover topics such as plant requirements, qualifications and standard operating procedures for each of the components mentioned above. The course will analyze case studies and real life situations.