Dr. Lucia Andreoni

Quality Assurance Consultant

Lead auditor of supplier audits Control and monitoring of supplier quality: verification of the application of national and international standards Management of Quality Agreement with suppliers Supplier questionnaires evaluation related to cGMP, ISO, TSE, Quality Manual

Lead auditor of supplier audits Control and monitoring of supplier quality: verification of the application of national and international standards Management of Quality Agreement with suppliers Supplier questionnaires evaluation related to cGMP, ISO, TSE, Quality Manual

Follow up and verification of the CAPA activities of Regulatory and Customer audits Audits to third party manufacturers

Release activities of products in the market, according both to release requirements and national/international regulations Internal and external audits

Deviation Reports management Implementation of Product Lot numbering system

Support to guarantee the application of cGMP rules in production processes Training Activity: basic, technical, on current Good Manufacturing Practices (cGMPs) and on current Good Documentation Practices (cGDPs) Internal audits Writing of Standard Operating Procedures Establishment License Application/Product License Application (ELA/PLA) revision.

Environmental monitoring, Validation, Non-conformity Program, Internal and external audits, Reconciliation, SOPs management, Batch Production Records and Material Batch Records. Project manager for the company Univax Biologics, Inc. Product: Intravenous Immunoglobulin (Human) “UnigamTM SD”. Project manager for the company SciClone Pharmaceuticals Product: “Thymosin Alfa 1”: coordination of the activities between Univax and Sclavo S.p.A. from early production stages to the final product.

In process control laboratory of Plasma Fractionation Plant: Gas Chromatography, HPLC, Spectrophotometry, Electrophoresis, Immunodiffusions, Elisa Techniques, Coagulation Techniques, Immunoblotting, Agglutination, Complement fixation, and other miscellaneous analysis.