Benefits/advantages to attending this course are:
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.
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.
Although the material is based on HPLC for small molecules, the principles taught and the practical session, may also be applied to analytical procedures for large molecules.
This workshop is based on ICH Q8, Q9, Q10 and Q11 which have been adapted to suit analytical procedures. It also provides an update on the proposed new chapter ICHQ14 (Analytical Procedure Development), proposed updates to ICHQ2 (Analytical Validation).
- 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
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 acceptance criteria target profile
- The Analytical Control strategy (identifying and controlling the appropriate method parameters)
- Risk Assessment Tools
- The qualification process
- Monitoring analytical procedures for acceptable performance throughout its 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.
Although the material is based on HPLC for small molecules, the principles taught and the practical session, may also be applied to analytical procedures for large molecules.
This workshop is based on ICH Q8, Q9, Q10 and Q11 which have been adapted to suit analytical procedures. It also provides an update on the proposed new chapter ICHQ14 (Analytical Procedure Development), proposed updates to ICHQ2 (Analytical Validation).
