AM Life Science (AMLS) recently partnered with a Boston-area gene therapy company to insert a Commissioning Qualification and Validation (CQV) subject matter expert (SME) at the pre-construction/construction phase of the facility design/build...
Read MoreAM Life Sciences (AMLS) has completed and turned over work for upgrades to a New England pharmaceutical company’s Engineering and Commissioning, Qualification, and Validation (CQV) Lifecycle program for equipment and systems. AMLS...
Read MoreAM Life Science (AMLS) promotes an approach to quality by design (QbD) that we call Early Quality Integration (EQI). The goal of this process is to better support biotechnology companies meet FDA...
Read MoreIn 2011, the FDA implemented a Quality by Design (QbD) pilot program to support their review and approval process. After gathering several years worth of research, the FDA decided to push forward...
Read MoreIn 2011, the FDA implemented a Quality by Design (QbD) pilot program to support their review and approval process. After gathering several years worth of research, the FDA decided to push forward...
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