--- title: Blog | Giovanna Cantoni description: CQV Advisor @ PQE Group --- [![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/) # Giovanna Cantoni #### CQV Advisor @ PQE Group [Home](https://www2.pqegroup.com/) [Blog](https://blog.pqegroup.com/) # **Latest Insights** [Regulatory Affairs ![](https://blog.pqegroup.com/hubfs/BANNER-USP%20Regulation%20-%20Plastic%20Contamination%20Risks%20and%20Single-Use%20Systems-1.jpg)](https://blog.pqegroup.com/regulatory-affairs/usp-665-1665-compliance-risk-assessment-for-biotech-and-api-manufacturing) 29 Apr 2026 ## [USP \<665\>/\<1665\> Compliance: Risk Assessment for Biotech & API Manufacturing USP \<665\> goes live in 2026. Are your polymer components compliant? Learn why early risk assessment is the key—and how to prepare.](https://blog.pqegroup.com/regulatory-affairs/usp-665-1665-compliance-risk-assessment-for-biotech-and-api-manufacturing) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=USP%20%3C665%3E/%3C1665%3E%20Compliance:%20Risk%20Assessment%20for%20Biotech%20&%20API%20Manufacturing&url=https://blog.pqegroup.com/regulatory-affairs/usp-665-1665-compliance-risk-assessment-for-biotech-and-api-manufacturing) [Quality by Design ![](https://blog.pqegroup.com/hubfs/Biotech_Quality%20by%20Design_Site%20Banner.jpg)](https://blog.pqegroup.com/quality-by-design/quality-by-design-approach-in-the-biotech-industry) 21 May 2024 ## [Quality by Design Approach in the Biotech Industry Discover the Quality by Design approach in the biotech industry, its implementation challenges, and the importance of building quality](https://blog.pqegroup.com/quality-by-design/quality-by-design-approach-in-the-biotech-industry) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Quality%20by%20Design%20Approach%20in%20the%20Biotech%20Industry&url=https://blog.pqegroup.com/quality-by-design/quality-by-design-approach-in-the-biotech-industry) [GxP Compliance ![](https://blog.pqegroup.com/hubfs/Banner%20sito_Shipping%20validation%20and%20the%20importance%20of%20the%20cold%20chain%20in%20the%20pharmaceutical%20market_1-1.jpg)](https://blog.pqegroup.com/gxp-compliance/shipping-validation-and-the-importance-of-the-cold-chain-in-the-pharmaceutical-market) 09 Jun 2023 ## [Shipping Validation and the Importance of the Cold Chain in the Pharmaceutical Market What is Shipping validation under the GOOD DISTRIBUTION PRACTICE, and what is the importance of the cold chain in the pharmaceutical market.](https://blog.pqegroup.com/gxp-compliance/shipping-validation-and-the-importance-of-the-cold-chain-in-the-pharmaceutical-market) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Shipping%20Validation%20and%20the%20Importance%20of%20the%20Cold%20Chain%20in%20the%20Pharmaceutical%20Market&url=https://blog.pqegroup.com/gxp-compliance/shipping-validation-and-the-importance-of-the-cold-chain-in-the-pharmaceutical-market) [Annex 1 ![](https://blog.pqegroup.com/hubfs/banner%20INSIGHT-ANNEX%201%20%202022%20%20Compliance_1_1.jpg)](https://blog.pqegroup.com/annex-1/annex-1-quality-and-compliance-update) 28 Nov 2022 ## [Annex 1 Quality & Compliance August 2022 Update Annex 1 was finally released in August 2022. It is time to consider the impact of these requirements on your own enterprise and organization.](https://blog.pqegroup.com/annex-1/annex-1-quality-and-compliance-update) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Annex%201%20Quality%20&%20Compliance%20August%202022%20Update&url=https://blog.pqegroup.com/annex-1/annex-1-quality-and-compliance-update) [Annex 1 ![](https://blog.pqegroup.com/hubfs/Annex-1-Critical-Utilities-technical-qualification-GMP-compliance.jpg)](https://blog.pqegroup.com/annex-1/new-annex-1-critical-utilities-gmp-compliance) 07 Apr 2021 ## [Critical Utilities GMP Compliance and new Annex 1 Find out about the new Annex 1 and the role of Critical Utilities in a wider-context Contamination Control Strategy.](https://blog.pqegroup.com/annex-1/new-annex-1-critical-utilities-gmp-compliance) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Critical%20Utilities%20GMP%20Compliance%20and%20new%20Annex%201&url=https://blog.pqegroup.com/annex-1/new-annex-1-critical-utilities-gmp-compliance) ### Categories - [Annex 1 (14)](https://blog.pqegroup.com/tag/annex-1) - [Artificial Intelligence (10)](https://blog.pqegroup.com/tag/artificial-intelligence) - [Audits (3)](https://blog.pqegroup.com/tag/audits) - [Clinical Research (8)](https://blog.pqegroup.com/tag/clinical-research) - [Commissioning, Qualification and Validation (CQV) (11)](https://blog.pqegroup.com/tag/commissioning-qualification-and-validation-cqv) - [CSV & Data Integrity (20)](https://blog.pqegroup.com/tag/csv-data-integrity) - [Cybersecurity (19)](https://blog.pqegroup.com/tag/cybersecurity) - [Engineering (13)](https://blog.pqegroup.com/tag/engineering) - [FemTech (13)](https://blog.pqegroup.com/tag/femtech) - [GxP Compliance (49)](https://blog.pqegroup.com/tag/gxp-compliance) - [IT Operations (6)](https://blog.pqegroup.com/tag/it-operations) - [Laboratory (3)](https://blog.pqegroup.com/tag/laboratory) - [Medical Cannabis (44)](https://blog.pqegroup.com/tag/medical-cannabis) - [Medical Device (20)](https://blog.pqegroup.com/tag/medical-device) - [Next Generation Products (4)](https://blog.pqegroup.com/tag/next-generation-products) - [Pharmacovigilance (12)](https://blog.pqegroup.com/tag/pharmacovigilance) - [Quality by Design (4)](https://blog.pqegroup.com/tag/quality-by-design) - [Regulatory Affairs (26)](https://blog.pqegroup.com/tag/regulatory-affairs) - [Startup (2)](https://blog.pqegroup.com/tag/startup) - [Training (1)](https://blog.pqegroup.com/tag/training) - [Veterinary (2)](https://blog.pqegroup.com/tag/veterinary) See all ### Recent Posts ### [Linkedin](https://www.linkedin.com/company/pqe-group/) ![new PQE logo white tagline](https://blog.pqegroup.com/hubfs/new%20PQE%20logo%20white%20tagline.png) ISO 9001 Certified compliance services provider since 1998.   ![Logo ISO 9001](https://blog.pqegroup.com/hs-fs/hubfs/Logo%20ISO%209001.png?width=125&name=Logo%20ISO%209001.png)   - Discover PQE - [Work with PQE](https://www2.pqegroup.com/careers/) - [Locations](https://www2.pqegroup.com/contact-us/#locations) - [About](https://www2.pqegroup.com/about/) - [Blog](https://blog.pqegroup.com/) - Useful Links - [Privacy Notice](https://www2.pqegroup.com/privacy-notice/) - [Cookie Policy](https://www2.pqegroup.com/cookie-policy/) - [Model of Organization](https://www2.pqegroup.com/model-of-organization/) - [Ethical Code](https://www2.pqegroup.com/ethical-code/) English - [English](https://blog.pqegroup.com/author/giovanna-cantoni) - [Español - España](https://blog.pqegroup.com/es-es/author/giovanna-cantoni) - [Español - México](https://blog.pqegroup.com/es-mx/author/giovanna-cantoni) - [Português - Brasil](https://blog.pqegroup.com/pt-br/author/giovanna-cantoni) - [日本語](https://blog.pqegroup.com/ja/author/giovanna-cantoni) - [简体中文](https://blog.pqegroup.com/zh-cn/author/giovanna-cantoni) CHANGE LANGUAGE Copyright **2024** | Proudly powered by **PQE Group Creative Team** [LinkedIn](https://www.linkedin.com/company/pqe-group) [![twitter](https://blog.pqegroup.com/hubfs/twitter-w.png) Twitter](https://twitter.com/PQEGroup) [Facebook](https://www.facebook.com/PQEGroup/) [Instagram](https://www.instagram.com/lifeatpqe) [YouTube](https://www.youtube.com/c/PQEGroup) [Xing](https://www.xing.com/pages/pqegroup)