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 of Risk Assessment and Control Strategy, 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.
1) Understand the lifecycle approach to method development and validation.
2) Identify an Analytical Target Profile for methods being developed
3) Use a Lifecycle Approach to method qualification.
Who Will Benefit:
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, and regulatory affairs/CMC personnel responsible for filings involving analytical methods.
} Introduction: Using a Lifecycle Approach for Analytical Procedures
} Introducing the Concept of the Analytical Target Profile
} Method Design and Development Using the ATP as a Tool
} Method Performance Qualification
Scheduled on April 07 2021 1:00PM EDT