PharmCourses Ltd, Amsterdam
11 & 12 June 2014
A Stability Indicating Method (SIM) is defined as a validated analytical procedure that accurately and precisely measures active ingredients (drug substance or drug product) free from process impurities, excipients and degradation products. High Performance Liquid Chromatography (HPLC) is the favoured method of detecting possible degradants and impurities.
Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability samples, testing of reference materials and to provide data to support specifications.
This course provides a comprehensive coverage of the method development and validation requirements that are essential to progress a pharmaceutical compound, at each stage of product development.
Upon completion of this course, delegates will have learned what is necessary to develop and validate methods for drug substance and drug product to comply with international regulatory guidelines.
Who Should Attend?
Scientists working with HPLC who need to further their understanding of the technique in order to develop better methods faster. Scientists who have to validate HPLC methods in accordance with current internationally-accepted guidance. HPLC technicians working in R&D laboratories, quality control laboratories and stability testing laboratories. Managers with a responsibility for generating regulatory submissions .