Mourne Training Services Ltd - Delivering training, consulting and auditing solutions for the pharmaceutical analysis laboratoryTraining courses on topics relating to chemical analysis of pharmaceuticals and biopharmaceuticalsMTS Training Course ListTraining course on method validation, verification and transfereLearning HPLC course from MTSMTS Course Calendar for 2018Click here for information on the course, Validation & Transfer of Methods for Pharmaceutical AnalysisClick here for information on the course, Validation & Transfer of Methods for Biopharmaceutical AnalysisClick here for information on the course, How to Develop Stability Indicating HPLC MethodsClick here for infomation on our data integrity training coursesClick here for information on our eLearning HPLC courseClick here for infomation on the course, How to Run HPLC MethodsClick here for infomation on the course, How to Troubleshoot HPLCClick here for infomation on the course, How to Develop HPLC Methods - Part 1Click here for infomation on the course, How to Develop HPLC Methods - Part 2

Validation and Transfer of Methods for Pharmaceutical Analysis

Click here to view the MTS Course Calendar for 2018

Please note that all MTS training courses are delivered using the English language by the MTS trainer, Mrs Oona McPolin BSc, MSc, CSci, CChem, FRSC.

Click here to view the bio for the MTS trainer, Mrs Oona McPolin
Validation and Transfer of Methods for Biopharmaceutical Analysis
How to Develop Stability Indicating HPLC Methods
eLearning HPLC Course
Data Integrity Training Courses
How to Develop HPLC Methods - Part 2
How to Run HPLC Methods
How to Troubleshoot HPLC
How to Develop HPLC Methods - Part 1

Validation & Transfer of Methods for

Course option 1: Pharmaceutical Analysis, or

Course option 2: Biopharmaceutical Analysis

Click here to find out more about the differences between the two versions of this course

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 ICH, EMA and FDA. The content will also prepare you for the expected changes in regulatory expectations, in particular, the update of ICH Q2(R1). The course is approved by the Royal Society of Chemistry for the purposes of continuing professional development.


The course is available in two versions, choose from either the Pharmaceutical version (test methods used for small molecules) or the Biopharmaceutical version (test methods used for large molecules, typically derived from biological or biotechnology processes).


The cost for this 3 day course, excluding VAT, is £1,225 GBP for the courses held in London, and €1,375 EUR for the courses held in Dublin and Berlin, if booked 1 month before the event.

Click here to view the course description for 'Validation and Transfer of Methods for Pharmaceutical/Biopharmaceutical Analysis'Click here to access the booking form and price list for this course

Training Courses from MTS

Validation & Transfer of Methods for Pharmaceutical Analysis (version for small molecules)


London, UK - Monday 25th to Wednesday 27th June 2018
@ Hilton Garden Inn, London Heathrow Airport

Dublin, Ireland - Wednesday 10th to Friday 12th October 2018
@ Crowne Plaza Hotel, Dublin Airport



What people say about this course:

"I’m quite new to validation and transfer but Oona made everything understandable and extremely clear. Very worthwhile, extremely useful." - S. Ip, Proctor & Gamble

"This was the best and most relevant training I have attended in the workplace." - L. Kinsella, Pfizer

"It was very useful both from a theoretical and practical point of view, which is very neat!" - E. Farkas, Mylan

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Validation & Transfer of Methods for Biopharmaceutical Analysis (version for large molecules)

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London, UK - Wednesday 20th to Friday 22nd June 2018 @ Hilton Garden Inn, London Heathrow Airport

Berlin, Germany - Wednesday 26th to Friday 28th September 2018
@ GLS Campus Berlin

London, UK - Wednesday 21st to Friday 23rd November 2018 @ Hilton Garden Inn, London Heathrow Airport


What people say about this course:

"The material of the course was excellent." - N. Reinoso, Owlstone Medical

"Oona is fantastic, she has a deep understanding of regulatory processes and validation." - A. Raposo, Oxford Biomedica

"Wish I had attended this course earlier. Was very useful." - H. Currie, Quotient

Click here to access the booking form and price list for this courseThis course is approved by the RSC for the purposes of continuing professional development

Who Should Attend?


The course is 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 and supervisors, quality control analysts and managers, quality assurance managers, and regulatory affairs managers.


Only Interested in Method Validation or Transfer/Verification?


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.


How to Develop Stability Indicating HPLC Methods

Do you need a stability indicating method? This 2 day course is suitable for both investigating whether an existing HPLC method is stability indicating, or for developing a new stability indicating HPLC method. You will learn:

 

- What exactly are stability indicating methods and why are they required?

- How HPLC method parameters, such as column and mobile phase, affect the chromatographic separation and how to find the best conditions to separate peaks due to degradation products;

- How to perform forced degradation stress studies to obtain potential degradation products; and

- How to investigate mass balance for analytical methods.

Dublin, Ireland - Monday 30th April to Tuesday 1st May 2018 @ Crowne Plaza Hotel, Dublin Airport


What people say about this course:

"The course gave a solid in depth overview of development of HPLC methods, which will help greatly in my current role & help with method optimisation for our clients." - A. Curley, PPD

"This was very useful course for me and I will definitely use the information provided at my next project." -
H. Halldorsdottir, Actavis

Learn how to develop stabiliyy indicating HPLC methodsClick here for the course description for 'How to Develop Stability Indicating HPLC Methods'Click here for the booking form and price list for this MTS course

Who Should Attend?


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

Click here to find out more about training courses from MTSClick here to find out about running MTS training courses at your companyClick here to find out more about training courses from MTSClick here to find out about running MTS training courses at your companyClick here to find out more about training courses from MTSClick here to find out about running MTS training courses at your company


Data Integrity in the Testing Laboratory

Data integrity continues to be a hot topic in pharma labs and MTS can help you to make sure that you are meeting with regulatory expectations (e.g. EMA, FDA, MHRA, etc.) in this surprisingly complex area. We typically provide a combination of training with auditing and/or consultancy services to support you to:

- Demonstrate your commitment to data integrity in the laboratory.
- Raise awareness for all staff to understand the issues surrounding laboratory data integrity and how it affects them.
- Strengthen laboratory quality management systems to improve data integrity and remove falsification potential.

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We have found that the nature of this topic is more amenable to training at the customer site which is customised to their particular needs and as such we do not offer open enrolment courses in this topic.



What People Say About Our Data Integrity Training:

"The course met all the needs on detailing data integrity & its importance in QC. I feel it was pitched at exactly the right level." - C. Clarke, Gilead


We have 3 courses related to data integrity which may be customised, or completely revised, as required to generate a suitable training course. A summary of each is provided below since they provide a good starting point for customised content.

How to Improve Data Integrity in the Pharma Lab
Focusses on improving laboratory data integrity and associated quality management systems by review of laboratory processes to identify data integrity risk, and implementation of appropriate solutions, paying particular attention to deficiencies that are commonly cited by regulatory authorities.

Introduction to Laboratory Data Integrity; cGMP in the Pharma Lab
Introduces the fundamental concepts of laboratory data integrity in the context of working within a quality management system and as such this course also acts as an introduction/refresher to laboratory cGMP.

Applying Data Integrity in the Laboratory; Minimising Error
Deals with the effects of analytical errors on laboratory data integrity. This involves building an understanding of the nature and sources of analytical errors so that their effects can be minimised during testing, leading to high standards of data integrity and reduced numbers of OOS/OOE results due to human error in the laboratory.

Click here to find out about running MTS training courses at your company


eLearning: Basic HPLC for Pharmaceutical Analysis (iLearn)

Who Should Attend?


This e-Learning course is ideal for anyone who wishes to use HPLC. It will suit the complete beginner but is also ideal for those who have been using HPLC and would like a more complete understanding of how it works. The important concepts of HPLC are introduced and will enable you to fully understand the following:

 

- The different types of HPLC and how they differ;

- The different types of available HPLC columns and how they differ;

- Why there are so many different mobile phase components and the ways in which they are combined to effect a chromatographic separation; and

- How components such as the pump, injector, detector and processor are combined to make a HPLC instrument.

This is an open enrolment training course and is delivered online by e-Learning using a combination of videos, exercises and an assessment. The content is equivalent to 1 full day of training. It is available 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. The course is delivered using e-MTS, our virtual environment for learning built on a Moodle platform.


What People Say About This Course:


"The course was very well laid out, dealing with the most important aspects of HPLC in a sequential manner i.e. stationary phase, mobile phase, detector etc." - P. Staunton


"It was a really great investment of my time. The time schedule was very flexible and I could use my time in the very effective way." - J. Yokota


This course is approved by the Royal Society of Chemistry for purposes of continuing professional development.


The cost of the course is £125 GBP, excluding VAT.

This course is approved by the Royal Society of Chemistry for the purposes for continuing professional developmentbanner_grey_


How to Run HPLC Methods

Click here for the course description for our eLearning HPLC courseg HPLC Methods'Click here for course descriptions of our off-the-shelf data integrity coursesClick here for more information on our eLearning HPLC course
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. The course is also run in collaboration with the chromatography consumables supplier, Phenomenex, in the UK and Ireland.

Who Should Attend?

This course is ideal for those who are new to HPLC.

Click here to find out about running MTS training courses at your companyClick here for the course description for 'How to Run HPLC Methods'Click here to view the Phenomenex HPLC training schedule for 2018HPLC training courses from Mourne Training Services Ltd


How to Troubleshoot HPLC

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.
The course is also run in collaboration with the chromatography consumables supplier, Phenomenex, in the UK and Ireland.


Who Should Attend?


This course is ideal for those who have experience of using HPLC and now want to develop their skills further.




What People Say About This Course:


"Enjoyed the course very much. Has consolidated what I already know but also gained new and valuable information. Clear, concise and good reference material going forward. Trainer’s style and presentation good." - 

M. O Loughlin, Roche


"Very good course – just what our analysts needed!!" -  J. Warwick, GSK


"Very informative and could save a lot of time in future troubleshooting." - D. Tuohy, Intertek



Click here to find out about running MTS training courses at your companyClick here for the course description for 'How to Troubleshoot HPLC'mobile_phase_bottles.jpg


How to Develop HPLC Methods - Part 1

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. In doing so you will learn how HPLC methods work even if you never need to develop a new method. The course is also run in collaboration with the chromatography consumables supplier, Phenomenex, in the UK and Ireland.


Who Should Attend?


This course is ideal for those who have experience of running HPLC methods and now want to learn how to develop new methods, or just to understand how they work.



What People Say About This Course:


"Very comprehensive content. Format laid out well – logical structure. Impressed with the amount of slides and exercises." - R. Walsh, Novartis

"Very good course, very valuable information. Exercises helped a lot in understanding some of the concepts explained." - M. Matos, Abbott

"Excellent cou
rse. V. Relevant, very well explained, not too technical too early in the presentation. Best course of its type attended to date." - P. Roche, Allergan
HPLC training courses from MTSClick here to find out about running MTS training courses at your companyClick here for the course description for 'How to Develop HPLC Methods - Part 1'


How to Develop HPLC Methods - Part 2
(for Challenging Separations)

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. The course is also run in collaboration with the chromatography consumables supplier, Phenomenex, in the UK and Ireland.


Who Should Attend?


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.

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.

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.

Click here to find out about running MTS training courses at your companyClick here for the course description for 'How to Develop HPLC Methods - Part 2'Click here to view the Phenomenex HPLC training schedule for 2018HPLC training courses from MTS

The cost for this 2 day course is €955 EUR, excluding VAT, if booked 1 month before the event.

Click here to view the Phenomenex HPLC training schedule for 2018Click here to view the Phenomenex HPLC training schedule for 2018