Quality by Design and Quality Risk Management have become standard in Drug Substance development. The principles laid out in ICH Q11 are the accepted norm for regulatory submissions. Unfortunately, confusion remains surrounding the relationship between QbD and QRA. Many teams struggle with a practical approach to identifying critical variability. The problem is especially pronounced in development where data can be tentative and limited. Smaller firms struggle to deploy the principles because of fear it is complicated and only for larger firms with more resources. They often forgo the benefits a structured approach brings to their development process and streamlined regulatory submissions.
This course will teach students the practical approach of identifying drug substance critical variability. You will learn how to identify and document Critical Quality Attributes, Critical Impurities, Critical Steps and Critical Process Parameters. Furthermore, you will learn to understand how the depth of product and process understanding influences overall risk. After attending, you will be able to identify data needed to reduce the overall risk to the synthesis. Course content is based on over a decade of practical experience and provides clear examples. The course serves as the essential foundation to supporting identification of critical control points and defining your overall synthesis control strategy.
Participants of the course will receive a free guide complete with examples that can be used as the foundation of their own procedure or work instruction.
At the completion of this session, you will be able to:
- Integrating Quality Risk Management with Quality by Design
- Define Critical Quality Attributes
- Define critical synthesis steps
- Learn to identify critical impurities
- Identify critical process parameters