--- title: Blog | Stefania Cislaghi description: GMP Compliance Advisor & Auditor @PQE Group - Stefania has been a project leader for different biotechnological products development, from engineering up to process validation and she has been responsible for a part of the development and production activities for more than 7 years. She has a long and strong experience working in pharma industries, from producing proteins involved in cancer development to developing processes and analytical methods for monoclonal antibodies to be used as orphan drugs. Reinforced by her Biotechnology degree and Master in Preclinical and Clinical Drugs Development, her wide knowledge include Quality Assurance, Toxicology, Clinical trials, drugs’ market, GMP regulated environments, as well as products compliance with EMA and FDA requirements. --- [![Logo PQE Group - azzurro - 2024](https://blog.pqegroup.com/hs-fs/hubfs/Logo%20PQE%20Group%20-%20azzurro%20-%202024.png?width=2000&height=721&name=Logo%20PQE%20Group%20-%20azzurro%20-%202024.png "Logo PQE Group - azzurro - 2024")](https://www2.pqegroup.com) - [Home](https://www2.pqegroup.com/) - [Industry](https://www2.pqegroup.com/industry/) - [Pharma & API](https://www2.pqegroup.com/pharma-api/) - [Medical Device](https://www2.pqegroup.com/medical-device/) - [Biotech](https://www2.pqegroup.com/biotech/) - [Startup](https://www2.pqegroup.com/startup/) - [Veterinary](https://www2.pqegroup.com/veterinary/) - [Services](https://www2.pqegroup.com/services/) - [Data Integrity](https://www2.pqegroup.com/data-integrity/) - [Digital Governance](https://www2.pqegroup.com/digital-governance/) - [Engineering](https://www2.pqegroup.com/engineering/) - [Commissioning, Qualification and Validation (CQV)](https://www2.pqegroup.com/commissioning-qualification-validation/) - [Quality Compliance](https://www2.pqegroup.com/quality-compliance/) - [Laboratory Excellence](https://www2.pqegroup.com/laboratory-excellence/) - [Regulatory Affairs](https://www2.pqegroup.com/regulatory-affairs/) - [Audits](https://www2.pqegroup.com/audits/) - [Training](https://www2.pqegroup.com/training/) - [Clinical Research](https://www2.pqegroup.com/clinical-research-services/) - [Pharmacovigilance](https://www2.pqegroup.com/pharmacovigilance/) - About - [About Us](https://www2.pqegroup.com/about/) - [ESG](https://www2.pqegroup.com/about/csr/) - [Women in STEM](https://www2.pqegroup.com/about/women-in-stem/) - Resources - [News & Press](https://www2.pqegroup.com/news/) - [Webinars](https://www2.pqegroup.com/webinars/) - [Blog](https://blog.pqegroup.com/) - [Careers](https://www2.pqegroup.com/careers/) - [Contact Us](https://www2.pqegroup.com/contact-us/) # Stefania Cislaghi #### GMP Compliance Advisor & Auditor @PQE Group - Stefania has been a project leader for different biotechnological products development, from engineering up to process validation and she has been responsible for a part of the development and production activities for more than 7 years. She has a long and strong experience working in pharma industries, from producing proteins involved in cancer development to developing processes and analytical methods for monoclonal antibodies to be used as orphan drugs. Reinforced by her Biotechnology degree and Master in Preclinical and Clinical Drugs Development, her wide knowledge include Quality Assurance, Toxicology, Clinical trials, drugs’ market, GMP regulated environments, as well as products compliance with EMA and FDA requirements. [Home](https://www2.pqegroup.com/) [Blog](https://blog.pqegroup.com/) # **Latest Insights** [GxP Compliance ![](https://blog.pqegroup.com/hubfs/Point%20Of%20Care_banner%20insight.jpg)](https://blog.pqegroup.com/gxp-compliance/point-of-care-manufacture-new-emerging-model) 27 May 2022 ## [POINT OF CARE MANUFACTURE (POC): a new emerging model for innovative products The Point of Care is a new approach for which drugs production sites should be as much close as possible to patients, to reduce the product lead.](https://blog.pqegroup.com/gxp-compliance/point-of-care-manufacture-new-emerging-model) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=POINT%20OF%20CARE%20MANUFACTURE%20(POC):%20a%20new%20emerging%20model%20for%20innovative%20products&url=https://blog.pqegroup.com/gxp-compliance/point-of-care-manufacture-new-emerging-model) [GxP Compliance ![](https://blog.pqegroup.com/hubfs/Covid%20Vaccine%20Technology%20Transfer%205%20reasons%2c%20risks%2c%20good%20practices%20-%20ext.jpg)](https://blog.pqegroup.com/gxp-compliance/vaccines-support-biotech-tech-transfer-good-practice) 25 Jun 2021 ## [Covid Vaccine Technology Transfer: 5 reasons, risks, good practices Find out from PQE experts how to perform a strong technology transfer to boost your vaccines production and meet compliance standards.](https://blog.pqegroup.com/gxp-compliance/vaccines-support-biotech-tech-transfer-good-practice) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Covid%20Vaccine%20Technology%20Transfer:%205%20reasons,%20risks,%20good%20practices&url=https://blog.pqegroup.com/gxp-compliance/vaccines-support-biotech-tech-transfer-good-practice) ### Categories - 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