Lifecycle Approach to Analytical Methods

The course will build on traditional concepts of method development, validation and transfer by introducing the Analytical Target Profile (which identifies what the method is expected to accomplish), fostering method understanding (using QbD concepts to explore the method operable region and stressing the importance of real samples in the environment where they will be tested) and demonstrating how these principles can be used iteratively as methods change location or evolve technically. This approach will be linked with current compendial requirements. There will be an opportunity for questions and answers at the end of the presentation.

Course Objective:

Understand the lifecycle approach to method development and validation.
Learn more about the three stages of an analytical method lifecycle.
Identify an Analytical Target Profile for Methods Being Developed
Understand how validation, verification and method transfer are interrelated
Comply with compendial requirements for verification with greater success and fewer resources

Course Outline:

Introduction: Using a Lifecycle Approach for Analytical Procedures
Stage 1: Method Design, Development and Understanding
Using an Analytical Target Profile to Guide Development
Using QbD Principles to Explore the Method Operable Design Space
Stage 2: Method Qualification
Integrating Validation, Verification and Transfer
Stage 3: Method Performance Verification
Using Change Control and Risk Assessment
Questions and Discussion

Target Audience:

Chemists
Supervisors
Managers or Directors from pharmaceutical (human and veterinary)
Generic or OTC companies or Contract Research Organizations who are responsible for development
Validation, Verification or Transfer of analytical methods personnel
Regulatory affairs/CMC personnel responsible for filings involving analytical methods

Gregory Martin

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