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Follow on Google News | How to successfully implement Quality by Design to create a formulation processBy: Quality by design This presentation is an introduction to the key components of QbD which are crucial for any individual look into to implement QbD in their business. Adoption of an integrated Product Quality Lifecycle Process facilitates innovation, continual improvement and strengthens the link between pharmaceutical development and manufacturing activities. • Introduction to QbD concept and update on ICH Q10 and QbD Pharmaceutical Quality Systems guideline • Overview of PAT technologies and industry examples in both development and manufacturing • Introductory overview of Product Quality Lifecycle Implementation (PQLI) and Introduction to the 4 Product Quality System elements (PQS) This conference will bring together both academia and industry experts to provide you in-depth knowledge about several topics such as: Advanced Systems in Quality by Design Processes QbD in biotherapeutics and formulation development Continuous process development and QbD Analytical method development Key presentations include: QbD at the interface of development to production Andreas Schreiner, Head Validation Manufacturing Science & Technology, Novartis Early screening of manufacturing to improve biotherapeutic design and selection Paul Dalby, Co-director of the EPSRC Centre for Innovative Manufacturing in Emergent Macromolecular Therapies, University College London Approaches in selecting and designing a safer biopharmaceutical Norma Scully, Small Molecule R&D, Eli Lilly & Company Plant-wide control for integrated continuous pharmaceutical manufacturing Richard Lakerveld, Assistant Professor, Delft University Of Technology The potential for imaging in the pharmaceutical industry Michel Ulmschneider, Scientific Specialist, Project Manager Spectroscopy and Chemometrics, F Hoffman - La Roche A G Shifting tides in pharmaceutical manufacturing — Making continuous processing a reality Marcel de Matas, Principal Scientist Formulation Science, AstraZeneca Development of data management and analysis platform for continuous secondary processes Simeone Zomer, Technical Manager, GlaxoSmithKline Application of novel PAT and QbD principles to enhancing material and process understanding Mingzhong Li, Principal Lecturer, De Montfort University For more information on the programme and speakers please visit www.smi-online.co.uk/ End
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