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Hands-on Tablet Development, including Pre-formulation, Formulation and Process Development


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Who should attend?

* Newcomers to tablet formulation development and manufacturing * Production operators who need a better understanding of their  products and how they have been developed * Analytical and QC staff who would benefit from understanding the tablet development and production process * Experienced personnel in one area of product development who need a broader overview * Project team members needing a broader insight into formulation development including preclinical, clinical, and project management representatives * Regulatory staff who would benefit from brief practical experience of the processes for which they are compiling dossiers. * Regulatory agency staff requiring practical experience

Details

Course overview

This unique 3 day course is designed to integrate the key elements of tablet development with hands-on, practical experience in a small scale, lab scale test facility. The course is made up of 1.5 days of theory with lectures on aspects of tablet development, followed by 1.5 days of sessions in which participants take part in experimental work directly linked to the theory content.

The course enables attendees to apply the theory learnt in the taught sessions, and also to directly observe the effect of formulation on product properties, and relate the theory to the practice of Quality by Design (QbD).  The course includes practical sessions using the Gamlen Instruments range with the Gamlen Dashboard 1062 – which is the only laboratory instrument able to measure material compaction properties as per the recently published USP<1062> monograph “Table Compression Characterization”.

Numbers are restricted to 10 participants for maximum benefit

Learning outcomes

  • Understanding of the relationship between Quality by Design, drug substance properties, formulation and process development
  • Practical experience of small scale tablet manufacture with direct knowledge of the relationship between formulation properties and tablet compressibility
  • Understanding of the roles of critical quality attributes, critical process parameters, and product control strategy in the application of the principles of QbD to formulation development

Contact

Judith Callanan
info@pharma-training-courses.com

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