Analytical Method Qualification Validation, Verification, and Transfer for Biotechnological Products

This interactive course will provide a practical and detailed overview how to consistently perform risk-based analytical method qualification and validation for all method and product lifecycle steps. The course attendants will understand how risks can be consistently assessed from available data sources and how this can be applied to each method lifecycle step. Options how to control risks will be illustrated 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). 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. The course content builds on ICH and local US and EU guidance documents with the intent to provide more practical guidance.

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 several case studies. Specific considerations for risk-based acceleration of analytical method qualification, validation, verification, and transfer options to support accelerated product development will be provided. Opportunities to use prior experience (analytical platform technology (APT)) to support accelerated product development and process validation studies will be discussed and case studies provided.

In the last part of this course, appropriate recovery options will be illustrated for those rare events when validation failures occur. An overview will be provided how analytical method performance capabilities contribute to the revisions of product specifications and are used in product out-of-specification investigations. 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

This course is for QA/QC personnel, CMC project managers and technical expert and CMC regulatory reviewers, as well as personnel in regulatory affairs, biotechnological and analytical development, validation, manufacturing, and research and development.

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

• Maximize the value of all method lifecycle steps for typical and accelerated 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 and DOE study designs
• Develop risk-based strategies and case studies for pre- and post-validation method transfers
• Use suitable verification study models
• Prepare appropriate method comparability study protocols when replacing 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
• Use analytical method capability when setting process/product acceptance criteria and dealing with OOS events