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  • Pharma
  • Training Courses | Online Live Stream

Stability & Shelf Life of Biologics

  • 9 – 11 May 2023
  • Online Live Stream 9:00 CEST – 15:00 CEST
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Stability & Shelf Life of Biologics

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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

meet the training leaders
Joerg Engelbergs | Fleming
Linkedin
Dr. Jörg Engelbergs
Regulatory-Scientific Expert and Assessor
Paul-Ehrlich-Institute, PEI
View trainer bio
Robert Zoubek | Fleming
Linkedin
Robert E. Zoubek
Principal Consultant
Granzer Regulatory Consulting & Services, Germany
View trainer bio
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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Stability & Shelf Life of Biologics online live training by Fleming_Agenda Cover
Stability Shelf Life of Biologics online live training by Fleming_Agenda Cover
Stability Shelf Life of Biologics online live training by Fleming_Agenda Cover
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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Training tickets

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Contact us

Andrea Weber | Marketing Manager | Fleming
Linkedin
Andrea Weber
Sr. Manager for Pharma
Phone: +421 257 272 100
Email: event.inquiries@fleming.events

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