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Methods and Reference Standards for CMC Analytical Studies

4-week online academy | 1 hour per week

17 June - 12 July 2019

Online Academy

Part of PTI’s new 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.

  • Examine analytical QbD and how it differs from traditional strategies
  • Define the difference between method verification, qualification and validation
  • Discover the common challenges of analytical methods and how to overcome them
  • Examine best practice when methods change
  • Explore the various biotech reference standards
  • Assess the various critical assay reagents
  • Learn best quality practices when managing a reference standard and critical assay reagent program

Dr Nadine Ritter is President and Analytical Advisor for Global Biotech Experts, LLC. She provides expertise in analytical test method selection and optimization for product characterization, release and stability testing; analytical test method qualification and validation, as well as pre- and post- approval product comparability studies, and assay bridging/technology transfers. In addition, she routinely performs third-party laboratory quality and compliance audits for small start-ups to multinational pharmaceutical corporations and contract testing laboratories.

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.

PTI online academies 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.


Modules are released on a weekly basis so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.

Watch the Online Academy Video

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