The aim of this two day course is to provide guidance on how QbD principles can be applied to analytical methods and identify the opportunities, not only for new development products, but also for drugs already marketed. This course will deal among others with the following questions:
What are the opportunities of applying QbD and life cycle approach to analytical methods?
What is the current status of analytical QbD (USP, FDA-EMA, FDA Draft Guidance Method Validation)?
How can the Analytical Target Profile increase regulatory flexibility?
Why is it important to have a clear understanding and expectation of method performance?
What is the impact of QbD on method development, validation and transfer?
What is the advantage of the 3-Stage lifecycle approach to validation?
How can QbD also benefit marketed products?
A number of interactive workshops will be provided throughout the two days which will enable delegates to to apply what they have learnt and to discuss the concepts in more detail. Delegates will have the opportunity to work through the whole QbD process by gaining “hands-on experience” using a number of case studies.