Process Robustness: The New FDA Paradigm

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

Instructor Profile:

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, Ms. Dunston 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, she has worked with US FDA agents to ensure compliance for her clients.

Her international experience 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 offered trainings on procedures from the V-suite to the manufacturing floor. Ms. Dunston works closely with the company’s staff to ensure a cohesive transition for non-compliance to policy approval.

Topic Background:

Global regulatory authorities expect pharmaceutical manufacturers to implement robust manufacturing processes that produce reliable pharmaceutical products. This expectation is demonstrated by the primary pharmaceutical provider with the implementation of a master validation program to include DQ, IQ, OQ, and PQ. What about those organizations that support the primary pharmaceutical manufacturer by providing certain cosmetic grade and/or technical grade raw materials, components and containers, labels, packaging materials or non-woven materials? 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.

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