Live Online Training Course: Method Validation and Transfer - December 2020

 

FREE WEBINAR: Strategies for HPLC Method Development

Strategies for HPLC Method Development

Tuesday 4th August 2020 at 15:00 BST/16:00 CEST/10:00 EDT
(Duration: approx. 40 min followed by up to 20 min for questions)

The benefits of using a strategic approach for developing HPLC methods are easily apparent. The numerous possible chromatographic parameters in a typical HPLC method make choosing the most suitable ones for a particular separation very daunting. In particular, how to select one column from the hundreds available? There are a number of different strategies which can be applied, these include: trial and error, changing one variable at a time; finding a method in the literature or finding a method in the literature for a similar compound; and sophisticated column screening experiments combined with computer modelling, peak tracking methods, experimental design and column comparison tools. In this presentation, current recommended method development strategies are reviewed and compared to give attendees an appreciation of the types of strategies which may be applied, so that they can identify the one which is most applicable for their method development needs.

The webinar will be delivered in our virtual learning platform, e-MTS, and provides a taster of our live online training courses. The webinar will be delivered by our trainer, Oona McPolin, an expert in analytical chemistry applied to pharmaceuticals and biopharmaceuticals with over 25 years of experience. This is a learning opportunity for all attendees and as such a Certificate of Attendance is available on request.

Simply fill in the sign up form on the MTS website if you would like to attend and we will get back to you soon to confirm your place. Places are limited and if after you sign up, you find that you can no longer attend for some reason, then it would be greatly appreciated if you could let us know.

FREE WEBINAR: Where do the Acceptance Criteria in Method Validation Come From?

Where do the Acceptance Criteria in Method Validation Come From?

Wednesday 29th July 2020 at 15:00 BST/16:00 CEST/10:00 EDT
(Duration: approx. 40 min followed by up to 20 min for questions)

One of the most difficult tasks when writing an analytical method validation protocol is to set suitable acceptance criteria, particularly for the characteristics of accuracy and precision. It sometimes seems that the values are just plucked out of the air! Available guidance documents, such as ICH Q2(R1), don't mention any numbers. In this webinar we will look at the relationship between inherent analytical error and validation acceptance criteria to give you an understanding of where typical values come from.

The webinar will be delivered in our virtual learning platform, e-MTS, and provides a taster of our live online training courses. The webinar will be delivered by our trainer, Oona McPolin, an expert in analytical chemistry applied to pharmaceuticals and biopharmaceuticals with over 25 years of experience. This is a learning opportunity for all attendees and as such a Certificate of Attendance is available on request.

Simply fill in the sign up form on the MTS website if you would like to attend and we will get back to you soon to confirm your place. Places are limited and if after you sign up, you find that you can no longer attend for some reason, then it would be greatly appreciated if you could let us know.

UPCOMING COURSE: How to Develop Stability Indicating HPLC Methods

UPDATED: MTS Course Calendar for 2020

Coronavirus Lockdown Offer - 50% off Training & Books

To assist in making learning opportunities more accessible during this global lockdown period, we are offering a 50% reduction on our books and online courses to the end of August 2020.

This applies to the following

Our Books:

An Introduction to HPLC for Pharmaceutical Analysis

Validation of Analytical Methods for Pharmaceutical Analysis

We are also offering free delivery but unfortunately it is possible that we may not be able to deliver to some locations.

Click here to purchase or find out more about our books.

On Demand Online Training:

Course: Basic HPLC for Pharmaceutical Analysis

This course 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.

Click here for more information.

Live Online Training:

Course: Validation and Transfer of Methods for Pharmaceutical/Biopharmaceutical Analysis

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.

Click here for more information.


Please click here to get in touch if you have any questions. Happy learning!

COVID-19: Business as Usual for MTS Consultancy Services

Mourne Training Services would like to assure our customers that our consultancy services will continue as usual during these difficult times of dealing with the effects of  the coronavirus (SARS-CoV-2) causing COVID-19. Obviously, travel to your site is no longer an option but we will continue to offer remote review of your issues and provide expert advice.

We can advise on all aspects of the chemical analysis of pharmaceuticals and biopharmaceuticals. Examples of our remote review service has recently included the review of:

• Out of trend (OOT) and out of specification (OOS) investigations;
• Analytical methodology for analysis of nitrosamines by LC-MS/MS
• Method validation protocol
• Pharmacopoeia method verification protocol
• SOP on method validation
• Analytical method data for submission of a variation

There are more examples on the MTS website, click here.

If this service would be of interest then please contact us to find out how we can help.

COVID-19: Update to MTS Training Schedule 2020

Alongside the most serious health and welfare effects of  the coronavirus (SARS-CoV-2) causing COVID-19 are those relating to businesses and the inability to travel. Regarding the training provided by Mourne Training Services, we have decided to introduce a live training version of our classroom based courses and cancel our open enrolment courses that were planned for London and Berlin in June 2020.

So if you would like to attend our courses from your home or workplace then you will just need a device with an internet connection to access our virtual environment for learning, e-MTS. The courses will run over 3 days in the same way that the open enrolment courses do, so it will suit learners who prefer to have a fixed time scheduled for training and can attend for the full number of days required.

Currently this only applies to the courses, 'Validation & Transfer of Methods for Biopharmaceutical Analysis', and, 'Validation & Transfer of Methods for Pharmaceutical Analysis', but depending on uptake, we may extend this option to other courses.

The dates for live online training are:

3rd to 5th June 2020: 
Validation & Transfer of Methods for Biopharmaceutical Analysis

 

24th to 26th June 2020:
Validation & Transfer of Methods for Pharmaceutical Analysis

 

There is more information on our online training option on the MTS website but please contact us if you have any questions.

We are also working on converting all of our courses to an on-demand online option which will suit learners who prefer a flexible approach to training and want to fit it around their existing commitments.

6 Free HPLC Tools on the Web

There are quite a few free tools on the web to help you use HPLC effectively. I have chosen six tools to share with you in this blog that I think should prove useful, in no particular order of preference. Please let me know if there are any others that you think should have been mentioned and I’ll include them in a future blog.

1. HPLC Troubleshooting Guide by Uwe Neue
This excellent troubleshooting guide by the late Dr. Neue takes the form of a series of questions and answers, where each topic starts off with a question describing a particular problem and the answer suggests a possible solution. This is then followed up with more information and builds up into a dialogue on each troubleshooting topic. The guide is well written in an easy to understand format and is presented as a pdf where the bookmarks have been carefully set up to allow you to navigate through the document easily and find the topic that relates to your troubleshooting enquiry. Click here to access the guide.


2. Successful HPLC - A Troubleshooting Guide

This guide from Thermo is in the form of a booklet which works through the symptoms of potential HPLC problems (visual, pressure, baseline and changes in chromatography) and provides advice on what could be causing the issue. It also includes some general, helpful advice for HPLC. I particularly like the advice regarding preparation and handling of solvents.  Click here to access the guide. 

3. HPLC Method Transfer Calculator 

Many manufacturers provide scaling calculators so that you can makes changes to HPLC method parameters and still retain similar chromatography. Recently scaling from HPLC to UHPLC and vice versa has become important as the new capabilities of UHPLC are exploited. One of these calculators is from Supelco, it is available online, and also as mobile app for Android and iPhone/iPad. It’s easy to use, you simply input your current method parameters and the change you wish to make to particle size, column length and internal diameter, the tool will provide the new method conditions. It works for isocratic and gradient methods. 

Click here to access the tool.

4. Liquid Chromatography Textbook

Liquid Chromatography (Chrom-Ed Series) by Raymond P. W. Scott, Library 4 Science

This useful textbook contains detailed descriptions of the components of liquid chromatography systems, e.g. pumps, detectors, etc., and is likely to be helpful to enhance understanding of these. It also covers silica and bonded phases together with some case studies.

The book is available as a free Kindle download. Full details are available at: http://www.chromatography-online.org/amazon_free.html

5. USP Column Equivalency Application

For those of you who don’t work in the pharmaceutical Industry, USP is ‘United States Pharmacopeia’. The column comparison tool that they offer is free to access and useful to anyone using HPLC, not just those who work with pharmaceuticals. The tool will allow you to find a column that is equivalent to one which you specify, or may also be used to find a column which has different selectivity, something that can be very useful during method development. Click here to start the application and when you have agreed to the disclaimer, click on ‘Compare Columns’. There are two database options, I recommend the bottom one, or PQRI (Product Quality Research Institute) Database. Select the column you are interested in from the drop down menu and, if you know there are acids and bases in your sample, tick the appropriate boxes. You can also specify a pH. There are two other options, either select ‘View Similar’ or ‘View Different’ as required. A full description of the approach and how the database was created can be accessed on the webpage.

6. MTS HPLC Calculator

And finally, I couldn’t leave out the HPLC calculator provided by yours truly! This free download includes a range of helpful calculations, none of which you couldn’t do yourself, but intended to be a convenient tool for those with a busy workload. It will help with equilibration times, preparation of mobile phase and using scouting gradients for method development. Click here to access the download page.