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 to update the guidance on method validation to be more applicable for the techniques commonly used in a pharmaceutical and biopharmaceutical setting.
On this half day course you will learn about the proposed changes to the ICH guidance. The aim 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:
Delivery:
This course is offered as a half day ‘virtual’ live online training event which is delivered over a 3 hours and 45 minutes period, from 12pm to 3:45pm, including a short break.
This course is suitable for:
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.
The course is an ideal follow-up for those who have attended either of our validation training courses: ‘Validation, Verification & Transfer of Methods for Pharmaceutical Analysis’; or ‘Validation, Verification & Transfer of Methods for Biopharmaceutical Analysis’
Course Fees:
£275 GBP or €315 EUR
Included in the course fees:
On this half day course you will learn about the proposed changes to the ICH guidance. The aim 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:
- Understand the proposed changes to ICH Q2 and their significance.
- Be aware of the key features of ICH Q14.
- Be able to implement the new requirements as appropriate.Delivery options for this course:
Delivery:
This course is offered as a half day ‘virtual’ live online training event which is delivered over a 3 hours and 45 minutes period, from 12pm to 3:45pm, including a short break.
This course is suitable for:
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.
The course is an ideal follow-up for those who have attended either of our validation training courses: ‘Validation, Verification & Transfer of Methods for Pharmaceutical Analysis’; or ‘Validation, Verification & Transfer of Methods for Biopharmaceutical Analysis’
Course Fees:
£275 GBP or €315 EUR
Included in the course fees:
- Comprehensive course hand-outs - The training book is provided as an electronic copy (pdf)
- Certificate of Attendance
- 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
