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Starts 28 October 2019
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

Part of the Biopharmaceutical and Biosimilar CMC Analytical and Lab Quality Series

Course Overview

Part of the online biopharmaceutical and biosimilar CMC analytical series, this course will provide you with the technical know-how required to 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 and biosimilar products.

In addition, you will learn about the quality, regulatory and monitoring aspects for different types of 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.