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11-20 August 2020
LIVE Online Academy,
4 sessions delivered over 2 weeks

Advanced CMC Analytical Studies and Lab Quality Practices

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 20% off if you book before 4 August

Live Online Academies

In light of the uncertain times we’re facing at the moment, 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, delivered in bitesize sessions of 1.5-3 hours online.

All sessions will be recorded and uploaded to your virtual learning environment which you will get access to for a month. As part of this you will also be able to access a forum where you can communicate with your trainer and peers on the course.

Delegates will receive login instructions within a week of the course start date. If you have any questions please contact, or you can see other live online academies here

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.

What will you learn?

Product specifications

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

Characterization and comparability

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

Degradation studies

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

Method validation

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

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).

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.

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