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.
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.
The course is designed for:
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.
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.
The course is designed for:
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.
