The complexity of everyday operations in the life sciences industry is continuously rising. To keep up with the regulatory requirements while maintaining the quality, efficacy, and safety of their products in focus, companies are required to constantly re-visit their approach to processes, technology, and information. Staying flexible and agile is the key to implementing a smooth transition from a monolithic document-centric approach to a data-driven and structured methodology.
In this webinar, we’ll explore new trends, learn about the potential and opportunities of implementing integral quality management platforms 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. We’ll also cover how to manage process dependencies (from a deviation, through CAPA, over change management all the way to variation submission).
Join us as Siniša Belina, Amplexor's Senior Life Sciences Consultant, will present the impact of the EU IDMP Implementation Guide on the Amplexor Life Sciences Suite. He will demonstrate the implementation of the required IDMP data fields as part of the ProductExpert solution as well as discuss what processes need to be in place to comply with the TOM within the RIMExpert solution.