Webinar on Process Robustness - The New FDA Paradigm

Description :

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)

Compliance Departments

Quality System Consultants

Production Management Teams

Technical Services Manager

Operations Departments

Process Engineers