4
6
by Design (QbD)
3] Quality
for Analytical Methods
7
3
2
1
4
5
10
8
5
15
Course no. SS0-9348
20 min
Quality by Design & Biochromatography seminars
presented by Dr. Chris Message, HPLC/ UHPLC
Product Specialist at Phenomenex
With 20 years of experience, Chris has been responsible for
HPLC/UHPLC product management, in addition to providing
specialist technical support to customers throughout the UK,
Ireland and Scandinavia with method development assistance
and training. This course is the result of the increasing number
of requests for training and support from those involved with
the analysis of biotherapeutics and those soon to enter this
challenging field.
This course is ideal for:
Those involved with method development; Those managing individuals and teams who develop analytical
methods and are keen to keep ahead of the requirements of regulators; Anyone wishing to develop
analytical methods that are not only more robust, reliable and fit-for-purpose today but also have an inbuilt capability for continuous improvement without impacting method validation.
The principles of QbD covered in this courses are as relevant to those using LC, GC or SFC. However, all
examples used during the training are in LC.
Course outline:
1. Examination of the ‘old analytical paradigm’ and the benefits of a QbD approach.
2. Goals for QbD in analytical methods.
3. “Design Space” in context.
4. The Analytical Target Profile (ATP).
5. Method design, evaluation and control.
6. Risk assessment and design space control.
7. Chromatographic measurement, columns selection and mobile phase – a QbD mind-set.
8. Potential impact of system specification and set-up.
9. Sample preparation – an over-view in brief for a QbD perspective.
10. Practical implications for the implementation of QbD.
11. Bringing it all together.
Date:
Register Today:
Online: www.phenomenex.com/IETraining | Tel: 01 247 5405 (Eire)
17. May 2017 – Clonmel