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Pharmaceutical Quality by Design: Debunking three big myths (Today)

Pharmaceutical Quality by Design (QbD) and Quality Risk Management (QRM) principles have become a mainstay in pharmaceutical development. However, several myths are prevalent that prevent wider acceptance of the concepts with smaller firms. The lack of understanding of pertinent quality by design methods prevent smaller firms from benefiting from the majority of what QbD offers. The benefits include a meaningful and well-structured Chemistry and Manufacturing Controls (CMC) section of the regulatory submission, a robust process that scales and transfers easily, and effective use of resources during the development process. This video discusses three myths that can be overcome enabling more companies to capitalize on the benefits of QbD. As with many myths, elements of truth support their formation and persistence. Most of the misunderstanding comes from the lofty expectations set by the biggest supporters. There is much discussion about real-time monitoring of process parameters and Real-Time-Release (RTR) of product. Debunking The Top 3 Myths About Quality By Design (QbD) https://lnkd.in/eGgFG_s