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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 understanding of your analytical procedures
• Improve performance of analytical procedures
• Reduce the number of OOS results due to poor method performance
• Improve the success rate of transfer/ verification
• Reduce non-value-added activities during investigations, development, verification and transfer of procedures
• Improve knowledge transfer and communication
• Keep you up to date with best practices and guidelines for analytical procedures

This 2-day training course integrates the following principles of QbD and the lifecycle management approach to analytical procedures into current practices (Development, verification and transfer) to improve and maintain the performance of analytical procedures.

• Knowledge gathering
• The analytical target profile (lifecycle acceptance criteria)
• The analytical control strategy (identifying and controlling the appropriate method parameters)
• Risk Assessment Tools
• The qualification process

Monitoring analytical procedures for acceptable performance throughout the lifecycle.A fun, hands on practical component using a Statapult has been designed to demonstrate setting a target profile, investigating and controlling variables for the procedure and qualifying the procedure against the predetermined target.
 
Case studies are included for development of a new procedure, a method transfer and a verification of a compendial monograph procedure.