This course will provide you with the requisite scientific knowledge and understanding of analytical method validation, verification and transfer to allow informed interpretation of current regulatory guidance from EMA, FDA and ICH, e.g. Q2(R1). The data generated using analytical test methods is essential for many of the critical decisions made in the pharmaceutical industry. To be confident in the integrity of this data it is crucial that the methods are fit for purpose. To demonstrate that a method is fit for purpose will require either a validation, verification or transfer study, depending on the source of the method in question.
This course provides a detailed explanation of how these studies are performed, enabling a full understanding of method performance characteristics and associated statistics, and how they are applied to the techniques used for analysing drug related samples.
The full course takes place over 3 days but if preferred, it is possible to attend the first 2 days only for a method validation course or the last day only for a method transfer and verification course. In the case of attendance on the last day only it is essential that delegates are familiar with validation characteristics since these are used for method transfer and verification. Click here for Agenda & Detailed Course Description (printer friendly)
Suitable for:
Anyone who needs to understand how methods are validated, verified or transferred, either to design and carry out the investigation, or to interpret the data generated. For example: Analytical chemists, laboratory managers/supervisors, quality control analysts/managers, quality assurance managers, and regulatory affairs managers.
Included:
Comprehensive course handouts; Certificate of Attendance; access to training resources via e-MTS; optional post training assessment (leading to Certificate of Training); post training support; and a copy of the MTS training book, Validation of Analytical Methods for Pharmaceutical Analysis. Lunch and refreshments are included for open enrolment training courses.
Availability:
Open Enrolment Training
Click here for Costs & Online Booking Form.
London, UK - 22nd to 24th April 2015
Venue: Hilton Garden Inn, London Heathrow Airport (formerly Jurys Inn Heathrow)
For early bird savings, book on this course before 25th March.
Dublin, Ireland - 27th to 29th May 2015
Venue: Metro Hotel Dublin Airport
For early bird savings, book on this course before 29th April.
London, UK - 30th September to 2nd October 2015
Venue: Hilton Garden Inn, London Heathrow Airport (formerly Jurys Inn Heathrow)
For early bird savings, book on this course before 2nd September.
Berlin, Germany - 30th November to 2nd December 2015
Venue: GLS Campus Berlin
For early bird savings, book on this course before 2nd November.
On-site Training
The course may be delivered at your site; this option includes customisation to meet your specific requirements. 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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