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Novel therapy methods require new approaches and manufacturing techniques, all with their own challenges. This session will examine how to overcome some of them through various examples and case studies. We will learn how a Virtual Reality Simulator can be used to train and monitor employees on targeted behaviors to avoid previously identified critical errors, the critical steps to take during a contamination event and how accurately identify the source of contamination, as well as cleaning processes for in lipid nanoparticle (LNP) delivery systems.
Annex 1, the European Union’s revised GMP requirements for the manufacturing of sterile medicinal products will take effect on 25 August 2023. As the document will also be adopted by PIC/S and WHO, the requirements become global…
This is your opportunity to pose your most pressing quality and regulatory questions directly to a panel of respected FDA thought leaders in the aseptic processing space…
Barrier Systems in Annex 1: RABS and Isolators Group Discussion | In the new Annex 1, Barrier Systems such as RABS and Isolators are mentioned up to 29 times…
The essence of how science and technology contribute to our industry is the creation of new knowledge, and then utilization of that knowledge to enhance human lives, and to solve the various issues facing our industry…