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Pharmaceutical Sciences Experts

Cristiano Cavazzoli

Head of Quality Assurance
Pharmaceutical Science
Accelera S.r.l.
Italy

Biography

The main function in this position is to conduct and supervise auditing activities to guarantee Accelera full compliance to Good Laboratory Practice (GLP) Principles and Good Clinical Practice (GCP).  Main responsibilities: • Collaborate proactively with Accelera Units to ensure quality, compliance, and maintenance of the adopted quality systems • Lead inspection performed to Accelera by Regulatory Agencies • Lead and support Facility inspection performed by external Sponsors or other Organizations • Lead CRO audits • Ensure that training records are current, available and audit ready by either external regulatory agencies/ accreditation organizations or QA audit functions • Provide and organize GLP, GCP, CV training to Accelera staff, according to training plans and Test Facility Management requirements. • Gather intelligence from conferences, seminars, journals, articles, government websites, or other means. Provide intelligence to other Accelera staff. • Maintain QA network internally and externally with GLP/GCP/GMP/CV Quality Assurance units and associations. • Review all Accelera SOPs for GLP and pertinent national and international regulations compliance and consistency. • Supervise QA activities for all projects are completed on time and according to QA SOP’s and to applicable regulations and guidelines: -Audit protocols/study plans, study phases inspection, process based inspections, draft reports and raw data review, final reports review and QAS preparation. • Issue of Quality Assurance Statement  • Periodic facility inspections and supplier joint inspections to Nerviano Medical Sciences Business Units and Companies • Train QA personnel

Research Interest

Quality assurance

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