Silvana is an experienced pharmaceutical professional with a strong background in all stages of product development covering GMP, GLP and GCP activities, review and approval of quality SOPs and batch record content.
Silvana has an extensive experience in project management of early phase clinical trials conducted under TGA CTN scheme, clinical trial document development, ethics and regulatory submissions and Good Clinical Practice (GCP).
She is capable of leading and managing projects through to completion. Silvana has over 15 years of pharmaceutical industry experience in the areas of GMP, cleanroom facility start-up, technical writing, quality management systems for sterile pharmaceuticals including vaccines and biologics, and research. Her experience in validation, QC, quality, regulatory and change management, along with her strong investigative skills, make her an asset in the areas of CAPA, OOS, deviations/non-conformances, risk assessment and gap analysis. She also offers excellent technical capabilities having worked in all areas of laboratory, sterile cleanroom operations and validation over her career.
Silvana has extensive experience in the development of QMS and other quality documentation required for regulatory approvals and compliance for the manufacture of medicinal cannabis products.
Silvana holds certification for quality auditor (CQA) awarded by the American Society for Quality (ASQ)