QbD :Lifecycle Management for Analytical Methods (2 day)

Venue: Window Conference Venue

Location: London, N1 8QG, United Kingdom

Event Date/Time: Oct 25, 2012 End Date/Time: Oct 26, 2012
Registration Date: Oct 25, 2012
Early Registration Date: Aug 22, 2012
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A QbD and lifecycle management approach to analytical method development and
qualification will result in a better understanding and fewer failures of analytical
methods due to more robust methods which produce consistent, reliable, quality data
throughout the lifecycle. This, in turn, will lead to less method transfer failures, OOS
results and method “incidents” when used in the routine environment. As the industry is moving towards applying Quality by Design (QbD) to process development - Is this also the way forward to improve and standardise our approach to method qualification?
This two day training course presents a brief overview of method validation according to
ICHQ2 (R1) and discusses the limitations of this approach in terms of its contribution to
failure of methods with regards to method transfer and generation of OOS results later
in the method lifecycle. It then introduces the concept of QbD in relation to analytical
methods and focuses on the application of a three stage approach of QbD and lifecycle
management. Finally a comparison of the current approach (ICHQ2) and the QbD approach is presented.
The course focuses on HPLC methods; therefore experience in developing, validating and transferring analytical HPLC methods would be an advantage to participants.
The material is presented by means of slides, handouts and participation of the attendees through discussion, case studies and hands on group exercises.
Course objectives
This course is designed to provide training in how to apply Quality by Design and lifecycle
management to the development and qualification of analytical methods. It aims to highlight the limitations of the current approach to method validation (ICHQ2) and the benefits to using the QbD approach.
Although the QbD and Lifecycle management approach is not yet officially recognised
for analytical methods, the course is based on the approach used for manufacturing processes and products as described in ICH Q8, Q9 and Q10. The course emphasises practical issues such as:
• Comparison of the traditional approach and QbD/lifecycle approach to analytical
• Applying the QbD and lifecycle approach to development and qualification of analytical methods
• Exploring and controlling variables of analytical methods
This course will deliver the tools to enable you to:
• Consider a QbD and lifecycle management approach to analytical methods
• Define an Analytical Target Profile
• Recognise the importance of understanding method variables of individual methods
• Develop more robust analytical methods
Who should attend
This 2 day course is valuable for Managers, Supervisors, Laboratory Analysts and Associates
involved in the development, validation, transfer or review of analytical methods
in the Pharmaceutical and related industries with daily responsibilities in the following
• Quality Assurance
• Quality Control Laboratory
• Regulatory Affairs
• Contract Laboratory
• Analytical Development Laboratory
• Training
Course outline:
Questions and answers will be taken throughout the duration of the course.
Day 1
8.30 am Registration and Coffee
• 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
• Advantages of QbD
4:30 pm End of course

Course Speaker
Dr Pauline McGregor
Twenty years in the pharmaceutical industry has included working for pharmaceutical companies and Contract Testing Laboratories in Canada and the UK.


13 Windsor Street, Islington
United Kingdom

Additional Information

Full Fee: 2 day course £1180.00 (+ VAT if applicable, see VAT NOTES) Discounted rate for registering and paying before 22 August 2012 - 2 day course £1062.00 (+ VAT if applicable, see VAT NOTES) Discount of 10% applies for booking 8 weeks in advance Discount of 10% applies for booking more than 1 delegate Discount of 10% applies for booking more than 1 course Maximum discount received is 15%