Course List
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:
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
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.
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.
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.
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?
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.
What People Say About This Course:
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.
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
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
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.