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Starting 21-22 June 2021

LIVE Online Course

Undertake a deep strategic analysis of biopharm CMC studies to increase efficiency and reduce costly non-compliance delays

For biotech and biosimilar products

Book with earlybird pricing now!

Receive £200 off if you book before 14 June 2021

Course Overview

Explore the technical challenges to designing and executing specific critical analytical studies with renowned expert Dr. Nadine Ritter. Practical examples will be provided as illustration for key studies and ample time will be allowed for discussion of designs and outcomes. Finally, tips on the suitable generation of internal study reports and the presentation of data for regulatory dossiers will be given.

Live Online Academies

Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses.

During these sessions students will learn through:

  • Direct interaction with the trainer during live sessions
  • Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
  • Revisiting recorded sessions with unlimited access for 30 days
  • Interaction with peers during live sessions and through the online forum

Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact

What will you learn?

Product specifications
Product specifications

Ascertain the main elements which are critical for establishing reliable and meaningful product specifications for biotech and biosimilar products

Characterization and comparability
Characterization and comparability

Review examples of method life cycle studies including what should go into written procedures for characterization and comparability methods

Degradation studies
Degradation studies

Examine what kinds of physical and chemical forced degradation studies are applicable to biotech and biosimilar products

Method validation
Method validation

Overcome the challenges of developing and validating process-specific host cell protein assays

Reference standards
Reference standards

Explore different types and uses of biotechnology reference standards and materials

Who is this course for?

This course would be useful for:

  • QC release and stability analysts
  • Stability program managers
  • Product scientists and test method technical experts (R&D and QC)
  • Process analytical chemists and process development scientists
  • Quality assurance specialists
  • GMP compliance auditors
  • Regulatory affairs CMC authors or reviewers
  • Analytical and stability laboratory managers (R&D through GMP)
  • Project managers with CMC responsibilities
  • Business managers with CMC responsibilities
  • Key staff from biotech academic incubators and small start-ups
  • Contract testing labs

The analytical side of CMC with course leader, Nadine Ritter

Nadine Ritter, President and Analytical Advisor at Global Biotech Experts, discusses how shortening timelines are impacting the analytical side of chemistry, manufacturing, and control (CMC).

Regulatory Affairs



It was great that there were real life examples and the trainer conveyed their ability to teach the class well on the topic.

Delegates of our live online academies said...

would attend another live online academy
found the course beneficial to their day to day role
would recommend the course to others

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

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.