1. Hands-on Tablet Development course.
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. Each day will consist of lectures on aspects of tablet development, followed by linked sessions in which participants take part in related experimental work. 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)
2. Powder Technology for Pharmaceutical Development and Manufacturing.
In this course we examine powder properties and their role in these important processes, so that attendees can understand
- The influence of drug substance properties on formulation development how and why particular tablet components are selected and what impact they have on powder properties and tablet behaviour
- Manufacturing method selection and the importance of powder flow Mechanisms of powder mixing and segregation
- Powder properties, Critical Quality and Material Attributes, and the Product Control Strategy
- Effects of blending behaviour and scale on Critical Process Parameters
- The relationship between input material properties and tablet properties
3. Tablet Process Development, Validation and the Application of QbD
This interactive workshop provides up-to-date, relevant and detailed information on the impact of Quality by Design (QbD) on the Development and Validation of tablet manufacturing processes. It will also study the identification and evaluation of Critical Product Attributes and Critical Process Parameters for tablets, and their implications for process control. We develop new concepts including the use of risk and process matrices for risk management. The latest ICH and FDA guidance on Quality by Design and Process Development, published in 2009, will be comprehensively reviewed.
4. Pharmaceutical Granulation and Compression
Three Day Intensive Course with an Emphasis on High Speed and Fluid Bed Granulation, Layering, Pellet Manufacture, Roller Compaction, Oral Dispersion Technology, Scale-Up, Transfer Technology, Melt Extrusion, Spray Drying and Compression Machinery. The aims of the Course are to provide a comprehensive and sound understanding of the theory and practice of tablet granulation and compression and to appreciate the various processes batch or continuous, that are available.
5. Preformulation Studies for Tablet Development
This unique 2 day course identifies the studies needed to characterise the physico-chemical properties of drug substances in the context of tablet development. Proper understanding of drug substance properties is essential for both candidate selection (during the Research process) and pharmaceutical development.
6. Stability Testing in Pharmaceutical Development and Manufacture
The course content will provide a comprehensive update on current trends which offer substantial potential savings in time and resources in a traditionally costly and complex testing area. Previous participants say that as a result of the course they have been able to significantly reduce testing in some areas and identified deficiencies in other areas. It will include opportunities for review of specific participant problems. The course will cover:
Recent regulatory changes affecting stability including
- The implications of implementation of ICH Q7, Q8, Q9, Q10 and Q11 for stability testing
- Changes to European GMP guidance with impact on stability testing including Annexe updates affecting product development, outsourcing and application of Quality Risk Management (QRM)
- Product Quality Reviews and the interpretation of stability data