MTS Recommends... Life Cycle Risk Assessment of HPLC Instruments

Life Cycle Risk Assessment of HPLC Instruments

By Paul Smith, R.D. McDowall
LCGC Europe
Volume 28 Number 2
Pages 110-117
Feb 01, 2015

"What does risk assessment in the context of the life cycle of a high performance liquid chromatography (HPLC) instrument really mean? This instalment of "Questions of Quality" will look at problems with an operational liquid chromatograph to see if they can be picked up in the performance qualification (PQ) or prevented in the operational qualification (OQ). The relationship between PQ and OQ and the design qualification (DQ) phases of the life cycle are also explored."

Course: How to Develop Stability Indicating HPLC Methods

Summary:
Pharmaceuticals need to be assessed for stability to support the assigned shelf life. Therefore, when analysing stability samples obtained from these studies analytical methods are required which are stability indicating, i.e. there is a measurable response which correlates with degradation, if present. HPLC is a popular technique for monitoring the decrease in drug and corresponding increase in degradation products due to its separating abilities. However, the HPLC method must be developed carefully to ensure that degradation products are both separated and detected appropriately.

This two day training course is designed to provide a thorough understanding of how to develop HPLC methods specifically designed for stability indicating analysis of pharmaceuticals. The course will describe strategies for performing forced degradation studies and selecting optimal HPLC method parameters to ensure that all relevant degradation products are separated.
Click here for Agenda & Detailed Course Description (printer friendly)

Suitable for:
This course is ideal for those who have some experience of using HPLC and need to ensure that they are stability indicating.

Included:
Comprehensive course handouts; Certificate of Attendance; access to training resources via e-MTS; optional post training assessment (leading to Certificate of Training); and post training support. Lunch and refreshments are included for open enrolment training courses.

Availability:

Open Enrolment Training
Click here for Costs & Online Booking Form.

London, UK - 19th & 20th May 2015
Venue: Hilton Garden Inn, London Heathrow Airport
For early bird savings, book on this course before 21st April.

Dublin, Ireland - 21st & 22nd September 2015
Venue: Metro Hotel Dublin Airport
For early bird savings, book on this course before 25th August.

Berlin, Germany - 26th & 27th November 2015
Venue: GLS Campus Berlin
For early bird savings, book on this course before 25th August.

On-site Training
The course may be delivered at your site; this option includes customisation to meet your specific requirements and may include ‘hands-on’ sessions using the instruments in your labs.
Contact us for a quotation. Visit the Course List page on our website for full details of all our available training courses in 2015.

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