Course List

  












Validation & Transfer of Methods for

Course option 1: Pharmaceutical Analysis, or

Course option 2: Biopharmaceutical Analysis

50% PRICE REDUCTION FOR LIVE ONLINE TRAINING OPTION IN JUNE


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.


This course is available in two options: You can attend an open enrolment training course, either as a live online training event, or in a classroom based event at an external location, or we can deliver the course at your site. On-site training allows customisation to meet your specific requirements.



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 information below is designed to help you decide which version of the course will be most suitable for your needs. The analytical techniques used to test traditional small molecule pharmaceuticals are typically different to those used for testing biopharmaceuticals, also known as biotherapeutics. Therefore, the key difference between the two versions of this course is that the examples and case studies used in the course are tailored to these different types of medicinal products. Additionally, since the typical acceptance criteria which is applied differs, the most relevant guidance can be provided to attendees.


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.


What People Say About This Course:



Open Enrolment Schedule 2020

50% PRICE REDUCTION FOR LIVE ONLINE TRAINING COURSES IN JUNE

 

Price List


Special Offer: 50% REDUCTION FOR LIVE ONLINE TRAINING IN JUNE 2020: £642.50 GBP/€717.50 EUR FOR 3 DAY COURSE


Validation & Transfer course (3 days)

Early bird offer: £1,285 GBP or €1,435 EUR 

Full price: £1,435 GBP or €1,605 EUR

 

Notes:

1. All prices quoted per person excluding VAT.

2. Early bird rate available up to 1 month before the date of training.

3. For external classroom based courses, course fees will be invoiced in GBP in the UK and in EUR in Ireland and Germany.

4. VAT will be applied at the relevant rate in the country where the event is being held (currently 20% in UK, 19% in Germany, and 0% In Ireland).

 

Validation course only (days 1 & 2)

Early bird offer: £890 GBP or €995 EUR

Full price: £990 GBP or €1,105 EUR

 

Transfer course only (day 3)

Early bird offer: £515 GBP or €575 EUR

Full price: £565 GBP or €635 EUR


Cancellations and Substitutions


Once made and accepted by MTS, course bookings are liable for payment. Payment is due prior to the course start date. Discounted rates (early booking rates and group discounts) require that payment is made at least 14 days before the start of the course. Cancellations prior to 3 weeks before the course date are subject to an administration charge of 25%. Cancellations received less than 3 weeks before the start of the course will not be refunded, although substitutions may be made at any time.

We reserve the right to change the programme, speakers, date or venue without notice, or to cancel an event. In the unlikely event of cancellation occurring, delegates will be notified as soon as possible and will receive a full refund of fees paid. MTS will not be responsible for discount airfare penalties or other costs incurred due to a cancellation.













eLearning: Basic HPLC for Pharmaceutical Analysis

50% PRICE REDUCTION ON THIS COURSE TO END AUGUST 2020


 


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How to Run HPLC Methods



Course: How to Run HPLC Methods

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 delivered using a combination of presentations and group exercises in which extensive use of case studies provides real life experience.


Learning objectives 


  • Understand what is meant by all the parameters in an HPLC analytical method.
  • Follow an HPLC analytical method to set up an HPLC system for analysis.
  • Run an HPLC analytical method and acquire chromatographic results.
  • Interpret chromatograms obtained from HPLC analysis.
  • Calculate analytical results for HPLC analysis.


This course is available in two options: You can attend an open enrolment training course at an external location (The course is run in collaboration with the chromatography consumables supplier, Phenomenex, in the UK and Ireland), or we can deliver the course at your site. On-site training allows customisation to meet your specific requirements. This may include ‘hands-on’ sessions using the HPLC instruments in your labs.


Who Should Attend?


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













How to Troubleshoot HPLC


Course: How to Troubleshoot HPLC


Learn how to find solutions for problems encountered when running HPLC analysis by diagnosing symptoms and implementing appropriate preventative measures. The 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.


Learning objectives


  • Understand how HPLC works and the role of each component in a HPLC system.
  • Understand how problems can arise in the individual components of a HPLC system.
  • Implement measures which prevent problems occurring.
  • Use a systematic problem-solving approach to HPLC troubleshooting.
  • Diagnose and resolve problems associated with HPLC.


This course is available in two options: You can attend an open enrolment training course at an external location (The course is run in collaboration with the chromatography consumables supplier, Phenomenex, in the UK and Ireland), or we can deliver the course at your site. On-site training allows customisation to meet your specific requirements. This may include ‘hands-on’ sessions using the HPLC instruments in your labs.


Who Should Attend?


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



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How to Develop HPLC Methods - Part 1 & Part 2


Course: How to Develop HPLC Methods - Part 1 & Part 2

The two parts of this course 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. These courses are available in two options: You can attend an open enrolment training course at an external location (The course is run in collaboration with the chromatography consumables supplier, Phenomenex, in the UK and Ireland), or we can deliver the course(s) at your site.


The computer modelling software, LC Simulator, from ACD Labs, is used during the courses to allow learners to see the effects of changes in HPLC condiitons.


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.


Learning objectives


  • Define the objectives for the development of a HPLC analytical method.
  • Effectively assess all the available relevant information relating to the desired method, e.g. pKa of the analyte.
  • Select and prepare a suitable sample or samples to be used for the method development.
  • Select suitable scouting conditions to find a suitable column and mobile phase system.
  • Optimise the chromatographic conditions to result in the best possible separation.


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.


PART 2:

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.


Learning objectives


Understand why some separations can be challenging and identify potential problem separations.

Apply strategies to achieve satisfactory separations for ‘complex’ samples with respect to:

  • Optimising gradient methods,
  • Sample preparation,
  • Detection methods,
  • Retaining very polar analytes,
  • Selecting columns,
  • Setting up scouting/screening experiments


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 Part 1 of the course, 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.



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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.



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Data Integrity in the Testing Laboratory


Course:  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


For training coures, 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.


Onsite trainingOnsite training


We have developed 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.



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Workshop: Out of Specification (OOS) Investigations



Workshop: Out of Specification (OOS) Investigations This one day workshop is designed to be a highly interactive exploration of best practice for OOS investigations in a GMP environment. The workshop is aimed at the investigation of all out of expectation (OOE) results, including out of specification (OOS), out of trend (OOT) and any atypical, aberrant or anomalous result.


The workshop explores the process for investigation of OOS results and the different phases of investigation, and also best practice investigation skills for effective and scientific OOS investigations. This includes:


  • Following a scientific rationale,
  • The expectations of regulatory authorities,
  • Gathering available evidence,
  • Generating potential hypotheses,
  • Testing those hypotheses,
  • Performing root cause analysis, using appropriate and effective techniques and tools.


Learning Objectives


  • Comprehend the significance of investigating OOS results effectively.
  • Understand the process for investigation of OOS results through the phases defined by regulatory authorities such as FDA and MHRA.
  • Formulate appropriate hypotheses regarding potential assignable causes for OOS results.
  • Conduct effective and scientific OOS investigations using appropriate techniques and tools.
  • Effectively evaluate data resulting from OOS investigations.
  • Perform root cause analysis for laboratory failures which lead to OOS results and design relevant CAPAs to prevent reoccurrence.


Who Should Attend? 

                  

Laboratory staff who are responsible for leading OOS investigations and everyone associated with analysis in the pharma laboratory who may be involved in an OOS investigation, e.g., analysts, reviewers, supervisors, managers, etc.



Open Enrolment Schedule 2020



Dublin, Ireland - Fri 16th Oct 2020


London, UK - Thu 19th Nov 2020

@ Hilton Garden Inn, London Heathrow



Price List


Early bird offer: £515 GBP or €575 EUR

Full price: £565 GBP or €635 EUR

 

Notes:

1. All prices quoted per person excluding VAT.

2. Early bird rate available up to 1 month before the date of training.

3. For external classroom based courses, course fees will be invoiced in GBP in the UK and in EUR in Ireland and Germany.

4. VAT will be applied at the relevant rate in the country where the event is being held (currently 20% in UK, 19% in Germany, and 0% In Ireland).


Cancellations and Substitutions


Once made and accepted by MTS, course bookings are liable for payment. Payment is due prior to the course start date. Discounted rates (early booking rates and group discounts) require that payment is made at least 14 days before the start of the course. Cancellations prior to 3 weeks before the course date are subject to an administration charge of 25%. Cancellations received less than 3 weeks before the start of the course will not be refunded, although substitutions may be made at any time.

We reserve the right to change the programme, speakers, date or venue without notice, or to cancel an event. In the unlikely event of cancellation occurring, delegates will be notified as soon as possible and will receive a full refund of fees paid. MTS will not be responsible for discount airfare penalties or other costs incurred due to a cancellation.