Process Robustness – The New FDA Paradigm

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

Angela K. Dunston

Angela K. Dunston has over 20 years of experience in manufacturing and laboratory quality and compliance in the pharmaceutical, biotechnology, and medical device (diagnostics) industries. Her expertise is in defining, implementing, and maintaining Quality Management Systems that are cohesive and properly interact with all areas of the organization.

During these 20 years, Angela has actively participated in global regulatory inspections to include US FDA in the capacity of host, SME, and scribe. Through consulting with a variety of companies, Angela has worked with US FDA agents to ensure compliance for her clients.

The international experience obtained has assisted global organizations such as Johnson and Johnson, the Croda Corporation, Novartis, Hospira, Sanofi Pasteur, and Quintiles to exceed regulatory expectations. She has authored company best practices manuals and has trained on those procedures from the V-suite to the manufacturing floor. Angela works closely with the company’s staff to ensure a cohesive transition for non-compliance to policy approval.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance