The QbD Toolbox

Course Instructor

Ranjit Barshikar

Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

If you are charged with exploring or implementing a QbD effort within your organization, where do you begin? Available guidance documents do not provide all of the information necessary to effectively implement such a program. Without proper understanding of how to establish QbD, your efforts may fail.

This accredited training course presents methods that assist R&D – QbD team members and process operations personnel in understanding Product & Process. As a part of Risk Management, Risk Priority Number is an extremely useful metric for risk management only when its defining scales are appropriate. This course aids participants in establishing scales that make sense.

The course includes basic simplified factorial analysis to reduce the sheer number of experiments, multivariate data analysis and software that will perform these experiments efficiently. At its conclusion, participants will have a toolbox of options for managing the details of a QbD program.

Upon completion of this course, you will be able to:

• Improve process and product knowledge
• Classify ways to identify CQA, CMA & CPP
• Develop risk analysis and management metrics, including Risk Priority Number (RPN)
• Explain experimental design space that aid in Design of Experiments
• Examine multivariate data using, e.g., response surfaces
• Identify importance of control strategy

COURSE OUTLINE

Module 1

• Why QbD?
• Difference between Traditional vs. Enhanced understanding of Product & Process
• Customer Expectations -Quality Target Product Profile (QTPP)

Module 2

• Identification of Critical Quality Attributes CQA by Risk Management
• Identification of CMA / CPP impact on CQA & Customers
• Ensuring effective Design Space of CPP

Module 3

• Design Space and Strategic Control Strategies
• Lifecycle Management