"I can recommend Pauline’s workshop if you want to learn more about this important topic. If you want to find out more about the future direction of ICHQ2 and the new ICHQ14 guideline on Analytical Development then this is a must!."
Phil Borman Director, Quality by Design Development Lead for Small Molecules at GSK
Location: BioCity, Scotland, UK. Save the dates June 3rd and June 4th 2019 Take advantage of the early bird discount by May 17th
Are you ready for ICH Q14: Analytical Procedure Development and the revision of ICHQ2(R1) Analytical Validation? These guidance’s, intended to be published by 2021, complement Q8 to Q12 and aim to improve regulatory communication between industry and regulators to facilitate more efficient, sound scientific and risk-based approval as well as post-approval change management of analytical procedures.
The enhanced approach holistically manages analytical procedures throughout their lifecycle.
It not only focuses on value added activities to development but also leads to higher success rates when applied to the transfer and verification of analytical procedures. It also integrates the management of procedures into current quality systems to ensure ongoing acceptable performance of procedures, regardless of the end user location.
Benefits/advantages to attending this course are:
- Improve performance of analytical procedures
- Improve understanding of your analytical procedures
- Reduce the number of OOS results due to poor method performance
- Increase success of transfer or verification analytical procedures
- Reduce non-value-added activities during investigations, development, verification and transfer
- Improve knowledge transfer and communication
- Keep up to date with best practices and guidelines for analytical procedures