Validation of Analytical Methods using Advanced Statistics and Automated Reporting
Kursinformation
Date
Wednesday, 23-Apr-2008 (9:00 - 15:00)
Quantitative analytical methods play a central role in all activities of the pharmaceutical industry. Indeed, it is on the results obtained from analytical laboratories that are taken all the critical decisions such as batch release of a drug product, establishment and verification of shelf life, bioequivalence between two drugs, pharmacokinetic studies or the diagnosis of a disease, and so on. The reliability of the decisions taken on this basis depends solely on the quality and consistency of the results obtained with the analytical methods. Furthermore, an increasing focus is actually made on the analysis, understanding and prediction of the statistical risks associated with the measurement results.This seminar will show you how SAS-based web-services incorporating the latest statistical tools can help you producing more reliable results faster and in a consistent manner – from individual results to the final report.
Agenda
- Introduction: Total Error concept in Validation and Transfer
- Statistical software presentation
- E-noval: for validation of analytical methods
- Seelva: for validation of Immuno-assays
- Transval: for transfer of methods from sender to receivers
- Use of total error concept and accuracy profiles for method validation in pharmaceutical analysis.
- Paperless Lab: Integration between LIMS and E-Noval
- Aufrechterhaltung des validierten Zustands
All talks will be held in English.
- Book your free seat as soon as possible!
- As this seminar is a sponsored event we need to charge a “No Show Up Happy Fee” of CHF 150.- if you do not show up or cancel your registration after 16th of April 2008
- This event is sponsored by Arlenda Laboratory Solutions and Vialis Paperless Lab Solutions.