GMP Compliant Test Methods for the QC Lab [QS-13E] – NEW

Goal: 
To ensure the reliability of analytical results the used methods must be fully validated according to the validation plan and regulatory guidelines (ICH Q2 (R1)). In this seminar you will learn how to develop and validate robust methods that fulfill these requirements.

Target Group:
Laboratory technicians, lab heads and QA-responsible working in a regulated lab environment

Content:

Method development:

  • Methods for purity determination, stability indicating methods and methods for assay
  • Coupled techniques (GC-MS, HPLC-MS)
  • Examples

Validation and transfer of analytical methods:

  • Regulatory background (HMG, ICH, PhEur, WHO Guide, EU GMP Guide)
  • Validation parameters (accuracy, precision, specificity, LOD/LOQ, linearity and range)
  • Limit test validation
  • Method transfer
  • Examples

Approach:
Lectures, discussions and case studies

Termin Eigenschaften

Datum 19.10.2017 09:00 - 20.10.2017 17:00
Einzelpreis Individual members CHF 940.00, Non-members CHF 1’130.00, Students/PhD/retired CHF 470.00
Referent Dr. Ilka König, Dr. Jochen Kirschbaum, Zentrum für Biomedizintechnik, Aachen, Deutschland
Kurssprache English
Ort
DAS-Kurse Olten (Angestellte Schweiz)
Martin Disteli-Strasse 9, 4600 Olten, Schweiz
DAS-Kurse Olten (Angestellte Schweiz), Olten
1'220.40CHF

Location Map


Sekretariat Weiterbildung SCG/DAS | ℅ Eawag | Überlandstrasse 133 | CH-8600 Dübendorf
+41 (0)58 765 52 00 | 
infodas@eawag.ch