|
|
| PDA/FDA Joint Regulatory Conference 2024 | The PDA/FDA Joint Regulatory Conference 2024, the only FDA co-sponsored pharmaceutical CGMP conference, is taking place 9 to 11 September in Washington, D.C. Now in its 33rd year, the conference will offer a comprehensive agenda with substantive technical sessions and practical case studies that provide insight into the effective application of Current Good Manufacturing Practice (CGMP). |
|
|
|
|
By Yadnyesh Patel, microbiology subject matter expert | All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method. |
|
|
|
By Ulrich Lein and Stefani Godoy Herrera, MAIN5 | The computer system validation (CSV)/computer system assurance (CSA) process is correlated with other departments besides IT and quality. Accordingly, all stakeholders must think ahead and define what they need. |
|
|
|
| Derisking Biomanufacturing: How A CDMO In Poland Could Help You | Article | By Nigel Stapleton and Slawomir Jaros, Mabion | The current geopolitical climate is leading drug developers to consider global manufacturing partnerships strategically. Identify a CDMO partner that will help protect your IP, save money, and mitigate risk. |
|
|
|
|
|
|
|
|
|
|
|
