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  Events - November 2012


HPLC Analytical Method Development and Validation (2 day)

27 Nov 2012 - 28 Nov 2012 - Window Conference Venue, 13 Windsor Street, Islington, London, N1 8QG



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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.

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.

Speaker:
Dr Roland Collicott, as an experienced consultant and trainer, provides assistance to the
pharmaceutical industry in the areas of chiral analysis , polymorphic characterisation, stability
studies, chemical analysis in a GMP environment, specifications and all aspects of
international CMC documentation. He also runs training courses to cover many areas of
analytical chemistry, particularly in chromatography, chiral and polymorphic analysis. He has
served as an expert witness and consulted in trials in Canada, UK, South Africa and Germany.



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