Alberto Bruno Email & Phone Number

Montecchio Maggiore, Veneto, Italia

Via S. Leonardo, 23, 45010 Villadose Ro

▪ Analysis of the GAPs of compliance according to the ALCOA+ requirements ▪ Analysis of the GAPs of compliance according to the requirements of 21 CFR part. 11 and EU GMP Annex 11▪ Planning of remedial activities (issuing of Remedial Plan and CapEx)▪ Management and supervision of the Remedial Team.

Via S. Leonardo, 23, 45010 Villadose Ro

▪ Quality Data Management;▪ Aseptic technical monitoring for the production of Active Pharmaceutical Ingredients by crystallization and Lyophilization;▪ Review and evaluation of the production documentation of the plant, ensuring compliance with the compliance requirements;▪ Ensure, through regular internal inspections, compliance with GMP in the production areas of API and warehouses (inspection readiness).

Padova Area, Italy

▪ Drafting and verification of the Distribution Agreements relating to the quality sections;▪ Management and interaction with external interfaces (suppliers and customers);▪ Risk analysis for the evaluation of suppliers (services, raw materials, first and secondary packaging materials)▪ Verification and approval of the Material Master Data (control plans, stability plans)▪ Writing and verification of SOP (Standard Operating Procedure), IO (Operative Instruction) and FORM

Padova Area, Italy

▪ Review and control of production documentation: batch record, master batch record, manufacturing formula;▪ Non-compliance management: CAPA and Corrections;▪ Out Of Trend management;▪ Redaction of Product Quality Review;▪ Managment of Deviations.

Pisa, Italia

Activities related to the Process Development:▪ Study of the quality attributes, definition of functional specification to develop the Manufacturing Knowledge Management▪ Definition and evalutation (with FMEA techniques) of the PPCs Design of experiments to verify PCCs, quality attributes and in-process controls. ▪ Conduction of the pilot plant, co-managing of production during validation studies and batch of validation production. ▪ Supervision of pharmaceutical product from the raw materials to the finished product Activities related to the production of IMPs:▪ Theoretical and practical activities to create awareness of the main techniques of preparation and primary and secondary packaging of Pharmaceutical products, in particular applied to the stages of development and production of the IMPs (Investigational Medicinal Products)▪ Design of the preparation and primary and secondary packaging method for the production of IMPs (Investigational Medicinal Products)▪ Theoretical and practical managment of equipment and the preparation and primary packaging systems▪ GMP, especially applied to production of IMPs