What’s New in ICH Drafts for Q2(R2) and Q14?

On this course you will learn about the proposed changes to the ICH guidance, Q2(R2),’Validation of Analytical Procedures’, and the new guidance Q14, ‘Analytical Procedure Development’, both currently available as draft documents.


Draft versions of the revision of ICH Q2, Validation of Analytical Procedures, and also the new guideline Q14, Analytical Procedure Development, were published on the 24th March 2022. The aim of these updated and new guidelines is to provide a harmonised and scientific approach to method development and update the guidance on method validation to be more applicable for the techniques commonly used in a pharmaceutical and biopharmaceutical setting.

The aim of this short course is to fully explore the updates to Q2 in terms of potential additional validation requirements and associated gap assessment when compared to current requirements, and also to provide an overview of the contents of Q14.

Learning Objectives

On completion of this training course you will:

  1. Understand the proposed changes to ICH Q2 and their significance.  
  2. Be aware of the key features of ICH Q14.
  3. Be able to implement the new requirements as appropriate.
How is this course delivered?

This course is delivered as a ‘virtual’ live online training event which is delivered over a 3 hours and 45 minutes period, including a short break, typically from 12pm to 3:45pm (but may depend on your time zone).

More about live online training

Total learning time = 3.5 hours

More about total learning time

The full agenda is provided in the course description.

The course may also be delivered as in-house training, either in the live online format or in a classroom based format at your site. In-house training allows customisation to meet your specific requirements.

More about in-house training

Who will deliver this training course?

All training courses are delivered by the MTS consultant, Oona McPolin. Some recordings of MTS webinars are provided below as examples of Oona’s presentation style.

Strategies for HPLC Method Development
Webinar Recording This webinar explored the different strategies, and combinations of strategies, which may be applied during HPLC method development. …
Where do the Acceptance Criteria in Method Validation Come From?
Webinar Recording One of the most difficult tasks when writing an analytical method validation protocol is to set suitable acceptance …
Who should attend this course?

Anyone with a good understanding of the current ICH Q2(R1) guidance who wants to learn about the proposed changes in the draft of ICH Q2(R2) and also would like to know how the guidance works in combination with the new proposed guidance on analytical procedure development, Q14.

This course is an ideal follow-up for those who have attended either of our training courses: ‘Validation, Verification and Transfer of Methods for Pharmaceutical Analysis‘; or ‘Validation, Verification and Transfer of Methods for Biopharmaceutical Analysis‘.

When can I attend this course in 2023?

Tue 20th Jun 2023 (12pm to 3:45pm BST/UTC+1)

How much does it cost?

£275 GBP or €315 EUR

Previous delegates on either of the courses, ‘Validation, Verification and Transfer of Methods for Pharmaceutical Analysis‘ or ‘Validation, Verification and Transfer of Methods for Biopharmaceutical Analysis‘ will receive a 10% discount on the course fees.

Included in your course fees:
  • Comprehensive course hand-outs – The training book is provided as an electronic copy (pdf) for both live online and classroom based options.
  • Certificate of Attendance
  • Optional post training assessment (accessed in e-MTS, our learning management system) which leads to a Certificate of Training.
  • Access to training materials via e-MTS
  • Post training support – Attendees can contact the trainer with questions that may occur when they apply their learning to real life situations.
  1. All prices are quoted per person excluding VAT.
  2. VAT notice for live online training: For UK business cutomers and non-business customers (B2C) from all countries VAT is charged at the UK rate (currently 20%). For EU business customers (B2B), the reverse charge can be applied on receipt of a valid VAT identification number and VAT will not be charged. For business customers outside of the UK and EU, VAT will not be charged.
Cancellations and Substitutions

Once made and accepted by MTS, course bookings are liable for payment. Payment is due at least 14 days prior to the course start date. 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.

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