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Starts 4 May 2020
Online Academy,
6 module series over 4 weeks

Methods and Reference Standards for CMC Analytical Studies

Gain a comprehensive understanding of technical standards for CMC analytical studies on this online course

Course 2/3 of the Biopharmaceutical and Biosimilar CMC Analytical and Lab Quality Series - Discover the key regulatory, technical and quality elements

In light of recent developments

If you would like to start the course sooner than advertised please contact us and we will arrange this for you as soon as possible.

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.

What will you learn?

Analytical QbD

Examine analytical QbD and how it differs from traditional strategies.

Analytical methods

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

Reference standards

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

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.


Purchase a place on all 3 online academies in the series and receive the final place at half price, saving you a total of £440 + VAT. Attending all 3 courses will provide you with a complete understanding of the regulatory, technical and quality requirements for CMC analytical studies.

To take advantage of this offer please get in touch with our training consultants at or call +44 (0)20 7551 9521. 

Regulatory and Compliance Requirements for CMC Analytical Studies

Discover key regulatory requirements for CMC analytical studies to ensure global compliance

Find out more
Product Specifications, Stability, Comparability and Similarity for CMC Analytical Studies

Learn best practices for ensuring the quality and efficacy of your products

Find out more

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.

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