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Analytical Data - Interpretation and Treatment
10-11 November 2008
Berlin, Germany

Please click here to view the program of this conference or course

To book for this program, just click on the option:

Book this option: Non-ECA Members (EUR 1690,--)

Book this option: ECA Members (EUR 1521,--)

Book this option: EU GMP Inspectorates (EUR 845,--)

Book this option: APIC Members (does not include ECA membership) (EUR 1605,--)


At this conference we offer a Conference Exhibition.
Please click here in order to view the registration form (PDF) for exhibitors.
LEARNING OBJECTIVES:
Recommendations of USP Chapter <1010>
Variability of Data
- Standard deviation, mean and averaging
- ANOVA
- Optimisation of precision
- Control charts: Shewhart and CuSum
- Out-of-Specification Results
How to Compare Analytical Methods
Approaches for Detection and Quantitation Limits
Product Quality Review
- How to assess trends

Objectives>/b>
This course will cover the following topics from UPS <1010>:
- The background and usage of the general chapter
- Good laboratory practices for the recording and reporting of data
- Measurement principles and variation
- Outlying results
- Comparison of analytical methods
It will also provide the participants with recommendations, tools and examples to apply statistical principles scientifically and pragmatically sound in their day-to-day
business. This includes, for example, questions from areas as OOS investigations, calibration models, trend analysis (a hot topic due to recent FDA-, EU- and PIC/Srequirements), detection and quantitation limit.
One of the main features of this workshop is the inclusion of exercises which will allow participants to gain ‘hands on’ practical experience in applying the statistical
methods described to real data sets. The objective is to ensure that participants using only pen and paper aided by a pocket calculator can become confident in the use of such methods. For this reason, the course is limited to 30 participants so that individual attention and support can be given.
Note: Attendees should bring a ruler and a pocket calculator (or a notebook with Excel®) for the workshops in order to fully benefit from the course.