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International Training

Stability & Shelf Life of Biologics

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KEY TOPICS

Guidance and Regulation for Stability of Biologics

Advantages and Limitations of Accelerated Stability Assessment

Biologics Degradation by Chemical, Physical and Microbiological Factors

Biochemical and Kinetic Approaches to Product Stability

Packaging vs Product Stability

Analytical Methodology for Stability Assessment

The Role of Excipients in Stability of Biologics

Transport and Shipping Impact on of Biologics Stability and Shelf-life

TAKEAWAYS & SPECIAL FEATURES

Understand

-  how to apply ASA to predict your product stability

- how to improve the stability by picking the right excipient

 

Learn

-  about guidance and expectations for product stability protocol

- to identify proper analytical methods for stability assessment

 

Gian

-  a comprehensive overview on stability and shelf-life regulatory landscape

-  harmonized ICH stability guidelines:Q1A-F and Q5C

 

Interactive way through stimulation of discussions and giving the participants an opportunity to advance their ideas

Individual case by case consultancy
with the trainers

All delegates will receive
comprehensive course documentation

Certificate of Completion issued by
the Trainers

5H+ of Networking with other industry
experts

Case studies from the trainer's experience

REGISTRATION

Delegate Fee

from 2196 € Buy

CUSTOMIZE THIS TRAINING TO YOUR COMPANY NEEDS

Based on your requirements, we will build a practical training including content tailored to your specific needs, our cutting edge methodologies and relevant modules from our training portfolio.

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JOIN US IN MUNICH

Four Points by Sheraton Munich Central Hotel

Schwanthalerstrasse 111, 80339, Munich

PARTNERS AND SPONSORS

This event is supported by the following companies.

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