events
  • Pharma
  • Training Courses | Online Live Stream

Stability & Shelf Life of Biologics

  • 16 - 18 May 2022
  • Barcelona, Spain | Online Live Stream 9:00 CEST - 15:00 CEST
Days
Hours
Minutes
Seconds
Online Live Stream

Stability & Shelf Life of Biologics

past evente
tickets
online live

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
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!

download brochure
Stability & Shelf Life of Biologics Training Course organized by Fleming_Agenda Cover
Stability & Shelf Life of Biologics Training Course organized by Fleming_Agenda Sneak Peek
Stability & Shelf Life of Biologics Training Course organized by Fleming_Agenda Sneak Peek_1
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
  • Learn about guidance and expectations for product stability protocol
  • Gain a comprehensive overview of stability and shelf-life regulatory landscape
  • Understand how to improve the stability by picking the right excipient
  • Learn to identify proper analytical methods for stability assessment
  • Gain harmonized ICH stability guidelines: Q1A-F and Q5C
  • Understand degradation of biologics by chemical, physical and microbiological factors
  • Learn how to find the correct packaging for biologics with low stability
  • Gain requirements for stability testing in Climatic Zones I-IV
  • Understand bracketing and matrixing to improve your product stability
  • Learn about acceptation of reduced stability data for new formulations
  • Gain 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
Previous
Next
Registration

Training tickets

Delegate Fee
FROM
2496€
BUY TICKET
Online Live Stream
FROM
1496€
BUY TICKET

Contact us

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

DOWNLOAD THE BROCHURE AND REVEAL THE FULL PROGRAM DETAILS

Name
Job
Company
Bio
Name
Description