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Starts 1 October 2019
Online Academy,
6 module series over 4 weeks

Regulatory and Compliance Requirements for CMC Analytical Studies

Discover key regulatory requirements for CMC analytical studies to ensure global compliance 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 regulatory and compliance clarity to ensure your analytical practices meet global requirements. Over 4 weeks you will learn what studies are needed and, crucially, when they must be completed to minimise development delays affecting your protein products (breakthrough or biosimilar).

In addition, you will gain best practice as you transition from R&D laboratory analytics to GxP requirements gaining an appreciation of the data required and the risks involved.

What will you learn?

Global regulatory requirements

Discover the global regulatory requirements for CMC biologics

CMC data sets

Learn what CMC data sets are required for all protein products, including biosimilars

CMC timelines

Examine when CMC analytical studies must be conducted during development and understand the CMC timelines for biosimilar and biopharmaceutical breakthrough products

GxP standards

Learn best practice for taking your R&D laboratory work to GxP standards and explore the GxP requirements for analytical CMC biologics

R&D quality and documentation

Discover the common R&D quality and documentation issues with biopharmaceutical and biosimilar products

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.