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Validation of Analytical Methods for Pharmaceutical Analysis
The data generated using analytical methods is essential for many of the critical decisions made in the pharmaceutical industry. To be confident in the reliability of this data it is crucial that the methods are fit for purpose. Analytical method validation is the process of demonstrating that a method is suitable for its intended use. This two day course provides a detailed explanation of how analytical methods are validated, 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. This knowledge will enable informed interpretation of the current regulatory guidance on validation, namely ICH Q2(R1) and guidance from FDA and EMA on bioanalytical methods.
The approach of this course is to focus on the principles of method validation thereby enabling application to different types of samples and analytical techniques. Case studies are employed to allow consideration of real life scenarios. Examples relating to small molecule drug substances and formulated products; to physiochemical methods for biotechnological/biological products; and to bioanalysis are included. Particular attention is paid to the most common analytical techniques used for pharmaceutical analysis, e.g., High Performance Liquid Chromatography (HPLC).
Course description (printer friendly)
Anyone who needs to understand how methods are validated, 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.
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.
Open Enrolment Training
London, UK - 10th & 11th April 2013
For early bird
savings, book on this course before 13th
March.
Click here for costs & booking form.
Berlin, Germany - 6th & 7th May 2013
For early bird
savings, book on this course before 8th April.
Click here for costs & booking form.
Dublin, Ireland - 5th & 6th June 2013
For early bird
savings, book on this course before 8th May.
Click here for costs & booking form.
London, UK - 6th & 7th November 2013
For early bird
savings, book on this course before 9th
October.
Click here for costs & booking form.
Berlin, Germany - 4th & 5th December 2013
For early bird
savings, book on this course before 6th November.
Click here for costs & booking form.
The training is delivered using the internet and a telephone over a series of 8 sessions at a time to suit you.
More information on live web-based training option for this course
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.
More information on on-site training



Open Enrolment Training
London, UK - 12th April 2013
For early bird
savings, book on this course before 15th March.
Click here for costs & booking form.
Berlin, Germany - 8th May 2013
For early bird
savings, book on this course before 10th
April.
Click here for costs & booking form.
Dublin, Ireland - 7th June 2013
For early bird
savings, book on this course before 10th
May.
Click here for costs & booking form.
London, UK - 8th November 2013
For early bird
savings, book on this course before 11th October.
Click here for costs & booking form.
Berlin, Germany - 6th December 2013
For early bird
savings, book on this course before 8th
November.
Click here for costs & booking form.
How to Develop Stability Indicating HPLC Methods
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
measureable 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.
Course description (printer friendly)
This course is ideal for those who have some experience of using HPLC.
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.
Open Enrolment Training
London, UK - 15th & 16th April 2013
For early bird
savings, book on this course before 18th March.
Click here for costs & booking form.
Berlin, Germany - 17th & 18th June 2013
For early bird
savings, book on this course before 20th
May.
Click here for costs & booking form.
London, UK - 11th & 12th November 2013
For early bird
savings, book on this course before 14th October.
Click here for costs & booking form.
Berlin, Germany - 9th & 10th December 2013
For early bird
savings, book on this course before 11th
November.
Click here for costs & booking form.
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.
More information on on-site training
Learn how to set up and run HPLC analysis with full understanding of all the method parameters such as the column, the mobile phase, the instrumentation, and sample preparation, and how to interpret and quantify the results of the analysis. This 1 day course will enable you to implement HPLC analytical methods by transferring the parameters from the method to your HPLC system.
Course description (printer friendly)
This course is ideal for those who are new to HPLC.
Comprehensive course handout; 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.
Open Enrolment Training
Dublin, Ireland - 20th May 2013
For early bird
savings, book on this course before 22nd
April.
Click here for costs & booking form
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 HPLC instruments in your labs. Contact us for a quotation.
More information on on-site training
Learn how to find solutions for problems encountered when running HPLC analysis by diagnosing symptoms and implementing appropriate preventative measures. This one day course will enable you to go back to your lab with a full understanding of why problems may arise with your HPLC system and give you the skills and knowledge to both prevent and resolve those problems.
Course description (printer friendly)
This course is ideal for those who have experience of using HPLC and now want to develop their skills further.
Comprehensive course handout; 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.
Open Enrolment Training
Dublin, Ireland - 21st May 2013
For early bird
savings, book on this course before 23rd April.
Click here for costs & booking form
On-site Training
The course may be delivered at your site; this option includes customisation to meet your specific requirements and may include a practical ‘hands-on’ session using the HPLC instruments in the customer laboratory. Contact us for a quotation.
More information on on-site training
This course is part 1 of a two part HPLC method development course. The two parts can be taken together as a two day training course for a complete method development programme, or alternately each day may be taken as a separate, standalone 1 day course. The training was designed in this way to allow maximum flexibility for individual learner requirements.
Learn how to select appropriate method conditions and perform suitable investigative experiments to obtain a set of method parameters which enables the desired separation for mixtures of analytes. This 1 day course will enable you to take a strategic approach to developing HPLC methods with an understanding of the factors which can be adjusted to manipulate the retention times of analytes.
Course description (printer friendly)
This course is ideal for those who have experience of running HPLC methods and now want to learn how to develop new methods.
Comprehensive course handout; 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.
Open Enrolment Training
Dublin, Ireland - 22nd May 2013
For early bird
savings, book on this course before 24th
April.
Click here for costs & booking form
On-site Training
The course may be delivered at your site; this option includes customisation to meet your particular requirements and may include customer method development projects. May also be tailored to be specific for pharmaceutical analysis. Contact us for a quotation.
More information on on-site training
This course is part 2 of a two part HPLC method development course. The two parts can be taken together as a two day training course for a complete method development programme, or alternately each day may be taken as a separate, standalone 1 day course. The training was designed in this way to allow maximum flexibility for individual learner requirements.
Learn how to implement strategies to achieve satisfactory separation for ‘complex’ samples and use computer modelling to develop robust and fit for purpose HPLC methods. This 1 day course will enable you to find solutions for difficult HPLC separations.
Course description (printer friendly)
This course is ideal for those who have experience of developing HPLC methods but want to increase their knowledge to deal with more challenging separations. Although designed as a follow-up to the course ‘How to Develop HPLC Methods - Part 1’, it is not a prerequisite. This course is suitable for learners who feel confident that they are familiar with all the content detailed in Part 1.
Comprehensive course handout; 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.
Open Enrolment Training
Dublin, Ireland - 23rd May 2013
For early bird
savings, book on this course before 25th
April.
Click here for costs & booking form
On-site Training
The course may be delivered at your site; this option includes customisation to meet your particular requirements and may include customer method development projects. May also be tailored to be specific for pharmaceutical analysis. Contact us for a quotation.
More information on on-site training
Introduces the information required to understand the technique of HPLC and how it is applied to pharmaceuticals. Includes a discussion of: the different types of HPLC; types of stationary phases used to pack HPLC columns; the solvents and additives used in HPLC mobile phases; and the instrumentation used for HPLC analysis.
This HPLC training course is aimed at beginners, but will also be useful for those with limited experience who wish to gain a better understanding of the technique.
This is an open enrolment training course and is delivered online by e-Learning through e-MTS using a combination of videos, exercises and an assessment. The content is equivalent to 1 full day of training. It is available either as a scheduled course where the training is delivered over a period of 1 week, with set deadlines for completion of exercises, or as on-demand training where all the training materials are available for 1 month and the learner decides when to watch the videos and complete the exercises and assessment.
Cost: £125 + VAT per person. Includes: access to all the training materials through e-MTS; tutor feedback on exercises via email; a certificate of training on completion of the assessment; and a copy of the MTS training book, An Introduction to HPLC for Pharmaceutical Analysis.
More information on this e-Learning HPLC course (including booking form)
This course is also available as UTrain, a pre-prepared training course which may be used for in-house training programmes.