Training Course
Syllabus:
Lifecycle Approach to Analytical Methods for Drug Products: Incorporating QbD Concepts into Method Development, Validation, Verification and Transfer
Course Description:
This highly interactive course is designed to provide participants with a lifecycle approach to developing and validating analytical methods, including elements aligned with QbD concepts. Some of the key aspects of the seminar include:
Learning how to apply QbD concepts to analytical methods Discussing the types of methods required for different drug products Understanding the types of impurities which must be addressed for drug products Discovering how a lifecycle approach can link method development, validation, verification and transfer Learning how ATP (Analytical Target Profile) can drive the lifecycle approach Determining the importance of linking method uncertainty to specifications Using a method feedback loop to facilitate method improvement This approach will be linked with current compendial requirements. There will be opportunities for questions and interaction throughout the course as well.
Course Outline:
Day One (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
Introduction: using a lifecycle approach for analytical procedures Types of methods required for various drug products Impurities which must be addressed for drug products Impurities Degradants Elemental impurities Residual solvents Method design: introducing the concept of ATP Practical exercise: developing an ATP
Day Two (8:30 AM – 4:30 PM)
Method development using the ATP as a tool Assay or uniformity Dissolution Stability indicating methods Practical exercise: approach to developing a stability indicating method Method validation: applying the concepts of ICH Q2 and USP <1225> Rationale for demonstrating the validity of an analytical method Lifecycle approach to method validation Design of validation experiments Establishing acceptance criteria Practical exercise: designing a validation protocol Method modifications: change control and method revalidation strategies Verification of compendial procedures Method transfer Troubleshooting analytical methods Questions and discussion |