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Event Details


Lifecycle Approach to Analytical Methods for Drug Products:

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Who should attend?

Chemists, supervisors, managers or directors from pharmaceutical (human and veterinary), generic


Top 5 Reasons to Attend this Seminar:

Learn how to use a Lifecycle Approach to apply QbD concepts to Analytical Methods
Learn how the Analytical Target Profile can drive the Lifecycle Approach
Discover how a lifecycle approach can link method development, validation, verification and transfer and continued method use
Learn about the importance of linking method uncertainty to specifications
Using a method feedback loop to facilitate method improvement

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. The course starts by introducing the Lifecycle Approach and discussing some of the key terms. By using the lifecycle approach, methods are more likely to meet their intended purpose, and scientists are more likely to have success during validation and transfer exercises. 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 interaction throughout the course.

Learning Objectives:

Understand the lifecycle approach to method development and validation.
Understand the different types of methods required for different types of drug products, and the various types of impurities which must be addressed
Identify an Analytical Target Profile for Methods Being Developed
Use an IQ/OQ/PQ Approach to Method Qualification
Develop Appropriate Protocols for Method Transfer
Comply with Compendial Requirements with Greater Success and Fewer Resources


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.


For Registration -


Note: Use coupon code  NB5SQH8N  and get 10% off on registration.


Note: Use coupon code NB5SQH8N and get 10% off on registration.


Chandrakala R

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