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Informa
Starting TBC in 2021

4-week online academy

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

Course 1/3 of the Biopharmaceutical and Biosimilar CMC Analytical and Lab Quality Series

Course Overview

The first course in the online biopharmaceutical and biosimilar CMC analytical series. This course provides the foundations for course 2 and 3 in the series. Learn more about the series here.

The 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.

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 lifesciences-training@informa.com.

What will you learn?


Global regulatory requirements
Global regulatory requirements

Discover the global regulatory requirements for CMC biologics

CMC data sets
CMC data sets

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

CMC timelines
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
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
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.

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...

4/5
for quality of content
85%
applied content during the course to their role
4/5
for quality of delivery

25% discount on Routledge books

As a student on the course you will receive a 25% discount on any Routledge books or eBooks. To view the full product range visit the Routledge website www.routledge.com.

Examples of books and eBooks within biopharmaceuticals include:

  • Fundamentals of Modern Bioprocessing
  • Cell Culture Bioprocess Engineering, Second Edition
  • PAT Applied in Biopharmaceutical Process Development and Manufacturing
  • Process Validation in Manufacturing of Biopharmaceuticals
  • Immune Aspects of Biopharmaceutical and Nanomedicines
  • Mathematical and Statistical Skills in the Biopharmaceutical Industry
  • And more

CPD Certified

Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.