Course offering number:0906-710
Course ID:
2289
Key PAT Concepts: Focus on Design Space
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This course is intended to help pharmaceutical industry professionals charged with enhancing and improving manufacturing efficiency for
existing drug products by using Process Analytical Technology (PAT). US FDA and EMEA guidance documents recommend critical evaluation
of both process and product parameters, using multivariate analysis. The Design Space focus uses historical batch data and the scientific
approach to convert “knowledge space” to “control space”. Design Space is a foundation for Design of Experiment and Desired State.
It is intended for:
• PAT & QbD team members
• Quality program managers
• Regulatory affairs personnel
• In-process analysts
• Human Resource and Training staff
• Tech transfer personnel
• New product developers
• Product financial planners
• Product release analysts
• Formulators
• Production managers
• Function cross-over personnel
• Operation personnel
Description
This 90-minute accredited training course provides the tools for identification of drug product and process variables using elements of risk
assessment. It establishes a pathway for ensuring drug product quality by setting limits for consistency - in both materials and operations.
Design Space principles become invaluable for improving both formulation decisions and scale-up exercises. The course also serves as a
foundation for experimental design.
Module 1:
• Examining and mining batch history
• Identifying CQA's and CPP's
• Tools for product and process optimization
• Understanding RPN: The Risk Prioritization Number
Module 2:
• Analytical software for design space applications
• Using CQA's and CPP's to develop control limits
• Process robustness and repeatability: avoiding skewed
controls
• Cyclic examination of results: Make it better!
Module 3:
• Using RPN for developing control schemes
• What goes into “control space?”
• Identify independent and dependent variables
• Which unit operations are preferred targets for control?
Question and Answer Session