Analytical Method Qualification, Transfer, and Validation for Biosimilars – New Course

Baltimore, MD
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Duration:  1 day
Time: 8:30 a.m. - 4:00 p.m.

This course will provide a practical and detailed overview on how to consistently perform risk-based analytical method qualification and validation for all method and product lifecycle steps. Options to control risks for each ICH Q2 (R1) method category, various production process steps (raw material, in-process, final product), and product life cycle steps (clinical phases I-III, commercial) will be covered. The course content builds on ICH and local US and EU guidance documents with the intent to provide more practical guidance. Specifically, the course will provide detailed strategies and case studies for suitable risk assessments for all method lifecycle steps and the resulting studies and protocol acceptance criteria. Regulatory-approved strategies for validation master plans, method qualification, verification, transfer, comparability (replacing method), validation continuum, and how to deal with failed protocol acceptance criteria will be presented with case studies for each method lifecycle step.

Information will be provided on support for biosimilar product development, specific considerations for risk-based acceleration of analytical method qualification, transfer, validation, as well as specification setting, specifically focusing on opportunities to reduce low-risk lifecycle steps to support accelerated biosimilar product development and process validation studies.

This course will provide the attendants with an understanding how risks can be consistently assessed from available data sources and how this can be applied to each method lifecycle step. At the end of this course, the attendants will be able to generate suitable protocols and acceptance criteria. Future regulatory submissions will be more robust and regulatory inspections can be readily passed.

Who Should Attend

QA/QC personnel, CMC project managers and technical experts, CMC regulatory reviewers, and individuals in regulatory affairs, biotechnological and analytical development, validation, manufacturing, and research and development will benefit from this course.
Event Location
Hilton Baltimore
401 Pratt Street, Baltimore, MD Get Directions

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More information coming soon.

Day 1

Upon completion of this course, you will be able to:

  • Maximize the value of all method life cycle steps for accelerated biosimilar product development
  • Develop strategies and the study designs for qualification and validation studies for various types of analytical methodologies
  • Use effective and compliant pre-validation method robustness DOE study designs
  • Develop risk-based strategies and case studies for pre- and post-validation method transfers
  • Prepare appropriate method comparability study protocols to analytical methods
  • Write defendable protocols and reports using risk-based protocol acceptance criteria
  • Use suitable statistical tools for each method lifecycle step
  • Use suitable recovery options for validation failures when they occur

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Hilton Baltimore

401 Pratt Street
Baltimore, MD ,

Stephan O. Krause, Director of QA Technology, AstraZeneca Biologics