Quality Management Crossroads

Presented by

Siniša Belina, Senior Life Sciences Consultant, Amplexor

About this talk

The complexity of everyday operations in the Life Sciences industry is constantly increasing. To keep up with the regulatory requirements while upkeeping quality, efficacy and safety of products in focus, companies are required to constantly re-visit their approach to processes, technology and information. Staying flexible and agile is key in obtaining success in this industry. In this webinar, we will take a look at new trends in the market, learn about the potential and opportunities of implementing holistic quality management platforms. We’ll take a look at those that seamlessly link not only activities within QA/QC departments, but also merge them into the comprehensive process that includes R&D, manufacturing, regulatory, labeling and other internal and external stakeholders. Join us to learn more about how to manage process dependencies (from a deviation, through CAPA, over change management, supplier management all the way to regulatory impact assessment and submission of variations), cope with the transition from the classic monolithic document-centric world towards the data-driven and structured environment of the future, and use the power of intelligent analytics to stay in control of your processes.

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