Dr. Giuseppe Di Nardo

Quality Responsible for the oncological products portfolio. Primary contact with manufacturing sites and in-market affiliates for an effective stewardship of the products from the manufacturing to the patients. Compliance to the GMP and to the most recent Quality and Regulatory standards (ICH, FDA and EU GMPs). Quality System Management (Complaints, Recalls, Deviations, Investigations, CAPA, Management of change). Quality Risk Management (ICH Q9). Project Management.

Quality Responsible in the manufacturing of API. Quality processes and GMP compliance. Author and trainer of SOP. Quality management (Deviations, Investigations, Complaints, Recalls, CAPA, Management of Changes). Quality Risk Management (ICH Q9). Product Stability, Process capability, trend analysis and author of the Annual Product Review. Supplier Qualification and Auditing (Internal and External). Implementation of new projects (Technical Projects, Technology Transfer and Validation Activities).

Preparation of NTA and CTD Dossiers, Application of International Regulatory requirements, assistance to marketing Authorization of Pharmaceutical Products.