"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
Lifecycle Management for Analytical Procedures
Location: Toronto
Save the dates August 20th and 21st 2019. Take advantage of the early bird discount by July 26th.
Manage your analytical procedures holistically throughout their lifecycle and reap the rewards.
This approach focuses on value added activities during development and 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.
Note: ICH Q14: Analytical Procedure Development and the revision of ICHQ2(R1) Analytical Validation are intended to be published by 2021. They 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.
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
Pauline McGregor is a member of the Royal Society of Chemistry and is listed on the RSC Directory of Consultants