Continued Process Verification and Process Monitoring

FDA's Process Validation Guidance emphasizes the importance of continual assessment of process performance and product quality throughout the product's lifecycle. By combining process control and improvement, you can align with the principles of ICH Q8 (R2) and the FDA's guidance for continued process verification, continuous improvement, and life cycle management. Join us as we present a structured and disciplined "Quality by Design" approach to help you achieve this objective.

While the pharma and biotech industries have focused extensively on the concept of the QbD "Design Space," less attention has been given to implementing robust "process control" systems that ensure consistent quality product outcomes. Our presentation will shed light on the critical need for process control to maintain process stability and drive consistent production of high-quality products. We will explore the routine analysis of process data at various levels to assess stability and capability, both within each batch and across different batches over time. Our system will be presented in detail, addressing important questions and challenges that arise. Furthermore, we will discuss the connections between this system and process robustness, offering valuable insights for process optimization.

AREAS COVERED IN THE SESSION:

• FDA Guidance regarding Process Validation and Continued Process Verification
• Building Blocks of QbD – Design Space, Process Control and Assessing Risk
• Process Control Strategy – Stability and Capability Methods
• Process Performance and Product Quality – A Systems Approach
• The Vision for Process Monitoring and Control Building Blocks
• Successful Deployment, Getting Started and Sustaining the Initiative
• Tips and traps – What to watch out for

WHO SHOULD ATTEND:

• Executives and Managers of Pharma and Biotech Companies
• Process and Manufacturing Engineers
• Quality Assurance Personnel
• Regulatory Affairs Professionals
• Quality Control Lab Personnel
• Quality Engineers
• Research and Development Scientists
• Biologists and Microbiologists
• Chemists and Chemical Engineers

Course Director: KELLY THOMAS

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation. Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.