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
Trainers
Dr. Tony Cundell worked for Merck Research Laboratories in Summit, New Jersey, as the Senior Principal Scientist in early phase drug development. Earlier in his career, he worked at a director level in Quality Control and Product Development organizations at the New York Blood Center, Lederle Laboratories, Wyeth Pharmaceuticals and Schering-Plough.
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