Join pharmaceutical industry expert Maria Sobusiak as she explores various approaches to setting particle sizing requirements for active pharmaceutical ingredients (APIs) during oral solid dosage product development. Maria will cover analysis of material properties, methods of analysis and approaches for unexpected process changes.
Maria will also answer frequently-asked questions on the following topics:
- How to lead research, from supplier selection through to powder trial sample analysis, method development, batch-to-batch control and scale-up
- How to define differences between batches, and implement controls during manufacturing
- What activities to undertake when changing the method of analysis at any stage of process development
発表者
About the speaker:
Maria Sobusiak is Pre formulation Projects Senior Specialist, where she is responsible for leading specialized research and development work. She currently focuses on the study of powder characteristics and particle size and shape assessment using laser diffraction methods. Maria also cooperates with the Medical University of Gdansk and delivers training, workshops and webinars on the topic of particle size analysis.
詳細
Who should attend?
- Researchers working in pharmaceutical research and development
- Specialists responsible for method development
- Scientists involved in QC release analysis
What will you learn?
- Understand how to select API quality parameters for your process
- Learn how to ensure full control of your API’s particle size in the drug product
- Understand what to do when there are unexpected changes in material quality
- Learn how to adjust your analysis method to control differences between API batches
- Understand how to implement guidelines for acceptance criteria for API particle size