Lifecycle Approach to Analytical Methods for Drug Products: Incorporating QbD Concepts into Method Development, Validation, Verification and Transfer  training seminars presented by ComplianceOnline register now on FindaSeminar.com

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Lifecycle Approach to Analytical Methods for Drug Products: Incorporating QbD Concepts into Method Development, Validation, Verification and Transfer  

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Seminar Summary:

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. (see full course description)

 

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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

Seminar Summary:

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. (see full course description)

print this agenda print agenda for the Lifecycle Approach to Analytical Methods for Drug Products: Incorporating QbD Concepts into Method Development, Validation, Verification and Transfer  training seminar

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