| "text": "What’s New in ICH Q2(R2) and Q14? | Mourne Training Services\nSkip to content\nSearch Toggle\nHome\nServices\nTraining\nConsulting\nBooks\nResources\nCourses\nValidation, Verification and Transfer for Pharma\nValidation, Verification & Transfer for Biopharma\nWhat’s New in ICH Q2(R2) and Q14?\nInvestigating OOS Results\nDeveloping Stability Indicating HPLC Methods\nChromatographic Integration\nHPLC Method Development\nHPLC Troubleshooting\nIntroduction to HPLC\nAbout\nContact\nBlog\nMenu\nSearch for:\nSubmit\nTRAINING COURSE\nWhat’s New in ICH Q2(R2) and Q14?\nOn this course you will learn about the recent changes to the ICH guidance, Q2(R2), ‘Validation of Analytical Procedures’, and about the new guidance Q14, ‘Analytical Procedure Development’.\nDownload Course Description\nBook Now\nSynopsis\nThe ICH guidance document on Validation of Analytical Procedures, ICH Q2, has been updated to Q2(R2). A new ICH guidance document on Analytical Procedure Development, Q14, has been introduced. The combination of these two documents provides guidance on management of the analytical procedure lifecycle from initial development through to validation and post validation changes.\nThe aim of this short course is to fully explore the updates to Q2 in terms of: the additional information that has been introduced, and the expected benefits; the potential additional validation requirements and associated gap assessment, when compared to previous requirements; and also to provide an overview of the contents of Q14.\nLearning Objectives\nOn completion of this training course you will:\nUnderstand the changes to ICH Q2 and their significance.\nBe aware of the key features of ICH Q14.\nBe able to implement the new requirements as appropriate.\nHow is this course delivered?\nThis course is delivered as a\n‘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).\nMore about live online training\nTotal learning time = 3.5 hours\nMore about total learning time\nThe full agenda is provided in the course description.\nDownload Course Description\nThe 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.\nMore about in-house training\nWho will deliver this training course?\nAll 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.\nStrategies for HPLC Method DevelopmentWebinar 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?MTS Helpdesk Webinar Recording One of the most difficult tasks when writing an analytical method validation protocol is to set …\nWho should attend this course?\nAnyone with a good understanding of the previous ICH Q2(R1) guidance who wants to learn about the proposed changes in ICH Q2(R2), and would also like to know about how the guidance works in combination with the new guidance on analytical procedure development, Q14.\nThis 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‘, prior to the finalisation of Q2(R2) and Q14 in November 2023.\nWhen can I attend this course in 2025?\nWed 19th Mar 2025 (1pm to 4:45pm GMT/UTC)\nWed 21st May 2025 (12pm to 3:45pm BST/UTC+1)\nBook Now\n2025 Calendar\nHow much does it cost?\n£250 GBP or €295 EUR\nPrevious 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.\nBook Now\nIncluded in your course fees:\nComprehensive course hand-outs – The training book is provided as an electronic copy (pdf) for both live online and classroom based options.\nCertificate of Attendance\nOptional post training assessment (accessed in e-MTS, our learning management system) which leads to a Certificate of Training.\nAccess to useful training materials via e-MTS.\nPost training support – Attendees can contact the trainer with questions that may occur when they apply their learning to real life situations.\nNotes:\nAll prices are quoted per person excluding VAT.\nVAT 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.\nCancellations and Substitutions\nOnce 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.\nWe 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.\nRelated Courses:\nValidation, Verification & Transfer of Methods for Pharmaceutical Analysis\nValidation, Verification & Transfer of Methods for Biopharmaceutical Analysis\nRelated content from our Resources Library:\nWhat is an Analytical Procedure Lifecycle?MTS Helpdesk Question: What are the elements of the Analytical Procedure Lifecycle, as … New Course: What’s New in ICH Q2(R2) and Q14?We are pleased to announce that we have a new short course on … ICH Q2(R2) & Q14 Now AvailableThe final versions of ICH Q2(R2) Validation of Analytical Procedures, and Q14 Analytical …\nMore…\nMTS\nHome\nAbout\nContact\nTerms & Conditions\nServices\nCourses\nTraining\nConsulting\nResources\nBooks\nResources\nBlog\nHPLC Calculator\n© 2025\nMourne Training Services Ltd\nPrivacy Policy\nOpen LinkedIn in a new tab\nOpen YouTube in a new tab",
|
| "description": "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.",
|
