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Division Analytische Wissenschaften der SCG

GMP Compliant Test Methods for the QC Lab


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


» Details and registration


Organizer:
Division Analytische Wissenschaften der SCG
Event Type:
seminar
Date:
10/19/2017 - 10/20/2017
City:
Olten
Country:
Switzerland

Contact:
Sekretariat Weiterbildung SCG/DAS
Verena Schmid, Lilo Weishaupt
c/o Eawag
Überlandstrasse 133
CH-8600 Dübendorf

Tel.: +41 (0)58 / 765 52 00
Fax: +41 (0)58 / 765 58 01
Mail: Send request Kontakt
Web: www.scg.ch



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