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.
Who should attend?
- Stability Managers/ Scientists/ Analysts/ Specialists
- Manufacturing Managers
- Regulatory Managers
- QA/QC Managers/ Specialists
- Formulation Scientists
- R&D Scientists
- Laboratory Technicians
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
Programme
- All training materials will be provided in digital form
- All delegates will receive digital and LinkedIn certificates
Trainers
Consulting Mirobiologist
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. Since 2013 Tony consults with a number of pharmaceutical, consumer health and dietary supplement companies, microbiology instrument manufacturers, contract testing laboratories and sterile compounding pharmacies in the areas of microbial risk assessment, regulatory affairs, and microbiological testing.
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