QbD Lifecycle Management for Analytical Methods (2 day)

Questions and answers will be taken throughout the duration of the course.
Day 1
8.30 am Registration and Coffee
9.00am
• Introduction
• Traditional approach to validation (ICHQ2)
• Exercise
• The limitations of this approach
10.45am Morning refreshments
11.00 am to 12.30pm
• Discussion of current approach (Groups share experiences of method
problems)
• Definition of QbD
• Overview of ICH Q8, Q9 and Q10
• Applying QbD to analytical methods (The three stages)
12.30 pm Lunch
1.30 pm to 3.00 pm
• Stage 1
• Gather Knowledge
• The Analytical Target Profile
• Exercise
3.00 pm Afternoon refreshments
3.15 pm to 5:00pm
• Method design and Method Understanding
• Risk assessment (exercise)
• Understanding and controlling variables (Robustness and Ruggedness)

9.00 am to 10.15 am
• Robustness study
• Design of experiments
10.15 am Morning refreshments
10.30 am to 12.00 pm
• Ruggedness study
• Conclusion of Stage 1
12.00 pm Lunch
1.00 pm - 2.30 pm Stage 2 - Method Qualification
2.30 pm Afternoon refreshments
2.45 pm to 4.30 pm
• Stage 3 - The lifecycle approach
• Continued method verification
• Quality systems - Change control and trending
• How can the QbD approach to translate to less
method transfer failures?
• Overview Comparison of Traditional and QbD
approach
• Advantages of QbD
4:30 pm End of course