In this training program, attendees will learn how process robustness tools and metrics can be utilized to enhance process understanding and control. The new FDA paradigm is shifting to the expectation that organizations certified by other standards such as ISO and EFfCI demonstrate process robustness. It is the obligation of the primary pharmaceutical provider to ensure process robustness throughout the supply chain.
This training will be 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 also:
Why Should You Attend:
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 will be 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 also:
- Discuss key concepts with process robustness
- Defines common terms
- Detail a methodical approach to robust process development
- Discuss tools and metrics that can be used during development or for ongoing process monitoring
Areas Covered in the Webinar:
- Key concepts associated with process robustness
- Define common terms
- Detail a methodical approach to robust process development
- Tools and metrics
Who Will Benefit:
- Sr. Directors/Directors
- QA Specialists (Senior Level)
- Compliance Professionals
- Quality System Consultants
- Production Management
- Technical Services Managers
- Process Engineers
Course Provider
Angela Dunston,
