QbD Approach to Analytical Method Lifecycle Design, Development, Validation, Transfer Goals and Objectives

This 2-hr webinar will provide you a comprehensive understanding of the requirements for validation, verification and transfer of pharmaceutical analytical methods. A lifecycle approach will be presented to establish the expectations for the method, after which key guidance documents will be reviewed.

Why Should You Attend:

This interactive course is designed to provide participants with an understanding of the requirements for validation, verification and transfer of pharmaceutical analytical methods. A lifecycle approach will be presented to establish the expectations for the method, after which key guidance documents will be reviewed. Different types of methods will be addressed, including those focusing primarily on the active, stability indicating methods and dissolution methods. The similarities and differences between validation, verification and transfer will be discussed and used to formulate protocols which are appropriate to a variety of situations. Establishment of acceptance criteria are a key component of these protocols, and the rationale for selecting criteria will be discussed. Some common issues which arise during these experiments will be discussed, including ways to recognize and address problems.

Areas Covered in the Seminar:

• Assessment of Participants Needs.
• Validation, following ICH Q2 and USP <1225>.
  • Stability Indicating Chromatographic Method with Degradates/Impurities.
  • Chromatographic method for Major Component.
  • Non-chromatographic methods.
• Verification of Compendial Methods.
• Transfer of Analytical Methods Between Laboratories.
• When to do validation, verification and transfer apply?
• Designing Validation Experiments to minimize time and resources.
• Sensible pre-validation experiments.
• Writing validation protocols and establishing practical acceptance criteria.
• Writing validation reports.
• Troubleshooting unexpected results.

Who Will Benefit:

Chemists, supervisors, managers or directors from pharmaceutical companies, generic companies or contract research organizations who are responsible for development, validation, verification or transfer of analytical methods, and regulatory affairs/CMC personnel responsible for filings involving analytical methods.