Recent increases in violations of Current Good Manufacturing Practices (the FDA reports the number of warning letters issued to pharmaceutical companies in 2017 remains significantly above 2013 levels) highlights the importance of manufacturers needing to proactively manage their compliance procedures to ensure a higher level of inspection readiness and achieve increased commercial benefits.
There is now a greater awareness of the risks and weak links that have developed in the quality management parts of leading pharmaceutical organizations.
Our free white paper opens up dialogue within the industry on this important subject. The guide looks at potential problems and reported cases of violations as well as advice on how risks can be mitigated and is available for download today.
Maetrics has longstanding experience applying new and complex standards consistently and efficiently while developing compliance strategies critical to your company’s success. Our third party support for MDR, IVDR, MDSAP, ISO 13485, and Supplier Quality Audits can deliver value and objectivity across the whole review and implementation process.
Founded in 1984, Maetrics is a global life sciences consulting firm focused exclusively on regulatory, quality and compliance solutions for Medical Device, Diagnostic, Pharmaceutical and Biotechnology companies.