Course: Optimization of Pharmacopeia Methods in QC

Phenomenex Training Seminars 2024: Optimization of Pharmacopeia Methods in QC

Course Summary

Validated methods ensure the quality of your analytical results, but often prevent the use of innovative column technologies. In this seminar, we will show you how to optimize QC methods within the scope of the allowed adjustments according to the European and US Pharmacopeia. We pay special attention to the conditions under which this is possible without a complete revalidation of the method.

Registration

Date and Location

24 October 2024

• 08:30 - 16:30 BST | 09:30 - 17:30 CEST
• Online

Price (per person)

£425 | 485 € | 480 CHF | 1200 PLN | 3600 DKK | 5100 NOK | 5350 SEK | 9300 CZK (+VAT, incl. PDF of the slides and certificate of attendance)

Course Outline

• What should be considered when optimizing validated methods?
• Criteria for the system suitability test
• Selection of the right column for a monographic method
• Allowed adjustments of chromatographic conditions
• The new harmonization between Ph. Eur. and USP
• Regulations for isocratic and gradient elution in HPLC
• Method optimization through variation of particle size, particle morphology, column length, and flow rate
• Use of new column technologies for pharmacopeia methods
• Influence of the mobile phase on method robustness
• Various case studies to clarify and deepen the content
• Optimization exercises and troubleshooting
• Special regulations for GC methods

Practical Skills Acquired

This course will enable you to use the allowed adjustments of Pharmacopeias to:

• Increase chromatographic efficiency and reduce runtimes
• Increase laboratory productivity and reduce costs
• Improve the quality of analytical results
• Fulfill the SST criteria more easily
• Troubleshoot non robust QC methods