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Starting TBC in 2021

4-week online academy

Gain a comprehensive understanding of technical standards for CMC analytical studies

Course 2/3 of the Biopharmaceutical and Biosimilar CMC Analytical and Lab Quality Series

Course Overview

The second course in the online biopharmaceutical and biosimilar CMC analytical series follows on from the first course on regulatory challenges. This course focuses on analytical method lifecycles as well as characterization and control of product reference standards. Learn more about the series here.

This course has been designed to provide you with the technical know-how, so you understand and select the right method verification, qualification and validation. During the 4 weeks, you will review the major life cycle elements and deliverables for biopharmaceutical/biosimilar products.

In addition, you will learn about the quality, regulatory and monitoring aspects of different types product reference standards and critical assay reagents.

Online Academies

BioProcess International Academy online courses are on-demand digital courses developed by our expert faculty providing learning on a range of technical topic areas.

Over 4 weeks students will learn through:

  • 6 modules, split up into multiple bitesize recorded videos
  • Quizzes to test your knowledge
  • Revisiting the content with unlimited access to all the materials for 3 months
  • Participating in the discussion forum to interact with other students
  • Interacting with the trainer through the forum during the course
  • Additional content such as materials and white papers available to download

Delegates will receive login instructions within a week of the course start date. If you have any questions please contact

What will you learn?

Analytical QbD
Analytical QbD

Examine analytical QbD and how it differs from traditional strategies.

Analytical methods
Analytical methods

Define the difference between method verification, qualification and validation, and discover how to overcome common challenges of analytical methods

Reference standards
Reference standards

Examine best practice when methods change and explore the various biotech reference standards

Critical assay reagents
Critical assay reagents

Assess the various critical assay reagents and learn best quality practices when managing a reference standard and critical assay reagent program 

Who is this course for?

This course is primarily aimed at professionals working in biopharmaceutical analytical CMC (CMC biologics). The materials are also appropriate for regulatory, project management and bioprocess professionals wanting to broaden their knowledge in CMC biologics.

Find out more about online courses...

BioProcess International Academy online courses are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.

On average, delegates of our online academies said...

for quality of content
applied content during the course to their role
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