Day 1
08.30 Registration and Coffee
09.00 Workshop Introduction
09.20 Regulatory aspect of product development
10.45 Morning refreshments
11.15 Quality by Design - the EUFEPS case study
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- The six stage model of Quality by Design
- How these stages are identified and used in practice
- Applying the model to preformulation, formulation, process development and process validation studies
12.15 Discussion
12.45 Lunch
14.00 Tablet development in practice
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- Principles of formulation development
- M aterial and product characterisation
- Developing stable processes
14.45 Key unit processes (1)
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- Mixing and blending
- Dry granulation
15.30 Afternoon refreshments
16.00 Blend uniformity assessment
We follow the development of a formulation from hand filled capsules to production tablet manufacture, reviewing blending options and actual results.
Sampling for accurate results
Why is it so difficult to get an accurate sample and what should you do to achieve this?
FDA Guidance on Blend Uniformity Testing
17.30 End of Day
Day 2
9.00 Case study - granulation end-point control
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- Granulation - what and why
- Methods of granulation
- Granulation process control
- Case history - developing a self-controlling process
10.00 Key manufacturing processes (2)
11.00 Morning refreshments
11.30 Key manufacturing processes (3)
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- Tablet compression
- Film coating
12.00 Wet granulation scale up
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- Effect of scale on key product attributes
- Implications for product quality and control systems
12.30 Lunch
14.00 Principles of process control and the application PAT
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- What is PAT?
- Which analytical techniques can be used? What do they measure?
- On-line vs at-line
15.00 Afternoon refreshments
15.30 PAT case studies
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- Use of NIR
- Use of Raman Spectroscopy
- Online monitoring of particle size
16.30 Closing Q&A
17.00 Course closes