Process robustness is not a new concept; however, it may be new to organizations that are not required to perform validation. There is more to a robust process than having a dosage form pass final specifications. Robustness cannot be tested into a product; rather, it must be incorporated into the design and development of the product.
This training is the first step in understanding how the performance of the product and process can be monitored to ensure robustness can be maintained. The training will discuss key concepts with process robustness, defines common terms, details a methodical approach to robust process development, and discusses tools and metrics that can be used during development or for ongoing process monitoring.
Areas Covered in the Session :
Key concepts associated with Process Robustness
Defines common terms
Details a methodical approach to robust process development
Tools and metrics
Who Will Benefit:
Quality Directors and Sr. Directors
QA Specialists (Senior Level)
Quality System Consultants
Production Management Teams
Technical Services Manager