Prediction of the Risks Linked to the Data Generated during the Life Cycle of Quantative Analytical Methods
Course Information
Date: Thursday, 4th of February 2010 (09:00 - 17:00)
Place: Hotel Victoria, Centralbahnplatz 3-4, CH-4002 Basel,
www.balehotels.ch/victoria/default-de.cfm (direct at the station SBB)
Target attendees: This Seminar is aimed for managers and staff in the areas of analysis, quality control, development and quality assurance, which are entrusted with meeting regulatory requirements of method validation and transfer.
Content: 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 [1, 2].
Therefore, at different steps of the life cycle of quantitative analytical methods it is crucial to know and manage these risks and this especially during the three following steps: in house method validation, method transfer to a receiving laboratory and routine analysis.
A recently developed methodology using a prediction interval (β-expectation tolerance interval) or accuracy profile allows to know and manage the risks to obtain results Out Of Specification [3, 4]. The utility and applicability of this interval for the different steps of the life cycle of analytical methods will be presented and illustrated by real examples [5, 6, 7]. Using the proposed approach, each analyst can predict the quality of the results that he will provide and thus earn confidence in the subsequent critical decisions made.
[1] International Conference on Harmonization (ICH): Quality Risk Management Q9, Geneva, 2005; http://www.emea.eu.int/Inspections/docs/ICHQ9Step4QRM.pdf.
[2] Process Analytical Technology (PAT) Initiative, US Food and Drugs Administration, Rockville, MD, 2004; http://www.fda.gov/cder/OPS/PAT.htm.
[3] Ph. Hubert and al., J. Pharm. Biomed. Anal., 36, 579 (2004)
[4] W. Dewé and al., Chemom. Intell. Lab. Syst., 85 (2007) 262-268.
[5] E. Rozet and al., Anal. Chim. Acta, 591 (2007) 239–247.
[6] E. Rozet. and al., J. Pharm. Biomed. Anal., 42 (2006) 64-70.
[7] E.Rozet and al., J. Chromatogr. A, 1158 (2007) 126–137.
The Seminar will be held in English.
Speaker: Mr.Francois Moonen CEO Arlenda Laboratory Solutions SA
Cost: Registration until 31-Dez-2009: CHF 490. --
For later registration: CHF 690. –