Stability Testing of Biological Drug Products
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Summary
This 3-day online training course will provide you with the necessary knowledge to build a well-defined testing program designed to confirm stability of your biological products. Besides technical knowledge needed to conduct stability tests, you will receive a comprehensive regulatory update and a deep understanding of all the critical product parameters affecting stability of your biological products.
Learning Objectives
- Understand the challenges of different biological products
- Learn how APIs, formulations and storage conditions affect stability
- Apply analytical methodologies for stability assessment
- Identify appropriate packaging and transportation
- How to accelerate stability studies
Key Topics
- Regulatory guidance on stability of biologics (EMA & FDA)
- Stress testing of biologics
- Packaging, storage and logistics
- Analytical methods, statistical analysis and stability data
- Product recalls
- Quality by design (QbD) principles for product stability
- ICH Q1 A-F
Who should attend?
- Stability Managers/ Scientists/ Analysts/ Specialists
- Manufacturing Managers
- Regulatory Managers
- QA/QC Managers/ Specialists
- Formulation Scientists
- R&D Scientists
- Laboratory Technicians
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 30 days
- Digital and LinkedIn certificates
