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Online Live Training Features

All sessions of this unique course online

Live interaction options between the delegates and trainer

Available via mobile, tablet or laptop

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Meet the training leaders

  • Dr. Jörg Engelbergs
  • Regulatory-scientific Expert
  • Paul-Ehrlich-Institut, Germany
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  • Dr. Robert E. Zoubek
  • Senior Consultant
  • Granzer Regulatory Consulting & Services, Germany
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Key topics

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

Key Takeaways

→ 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
→ 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
→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


Delegate Fee

from 1396 € Buy


Based on your specific needs and goals, we will build a training program that will equip your employees with the right set of skills and practical knowledge to achieve your organization's targets.

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