Training features
Fully online
All sessions of this unique course online
Live interaction
Live interaction options between the delegates and trainer
On any device
Available via mobile, tablet or laptop
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training
Brochure
Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!
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key training
Topics
Guidance and regulation for stability of biologics with focus on biotech products
Advantages and limitations of accelerated and stress stability assessment
Biologics degradation by chemical, physical and microbiological factors
Biochemical and kinetic approaches to product stability
Analytical methodology for stability assessment
Packaging vs product stability
The role of excipients in stability of biologics
Transport and shipping impact on stability and shelf-life
Benefits of attending
- Understand
- How to apply accelerated and stress stability assessment to predict your product stability
- How to improve the stability by picking the right excipient
- Degradation of biologics by chemical, physical and microbiological factors
- Bracketing and matrixing to improve your product stability
- Learn
- About guidance and expectations for product stability protocol
- To identify proper analytical methods for stability assessment
- How to find the correct packaging for biologics with low stability
- About acceptation of reduced stability data for new formulations
- Gain
- A comprehensive overview on stability and shelf-life regulatory landscape
- Harmonized ICH stability guidelines: Q1A-F and Q5C
- Requirements for stability testing in Climatic Zones I-IV
- A contact with key leaders and regulatory authority to build up your network
Testimonials
Engaging and a lot of discussions!
Hii Chung ShiiHead of R&D, Prestige Biopharma
“Stability & Shelf Life of Biologics” online live training taught by Robert Zoubek from Granzer Regulatory Consulting and Joerg Engelbergs from PEI was very informative and effective.
Ina Sigal-BatikoffQC Projects and Validations Section Manager, Kamada
A very exciting training course to be up-to date in the field of CMC aspects of Biopharmaceutics and specially in the stability topics.
Javier IbarzoCMC Regulatory Affairs, Almirall
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