Objectives of the Presentation:
- 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
Why Should you Attend:
The FDA's Process Validation Guidance calls for "Continued Process Verification" in Stage 3 of the guidance which focuses on continual assessment of process performance and product quality throughout the life of the product. Combining process control with process improvement creates a system that satisfies the direction of ICH Q8 (R2) and FDA's guidance for continued process verification, continuous improvement and life cycle management. This presentation describes a disciplined and structured "Quality by Design" approach to achieve this objective.
Ronald D. Snee,
President and Founder ,
Snee Associates, LLC
Ron Snee is the Founder and President of Snee Associates, a firm dedicated to successful implementation of process and organizational improvement initiatives. He provides guidance to senior executives in their pursuit of improved business performance using Quality by Design, Lean Six Sigma and other approaches that produce bottom line results. He has played a leadership role in 32 major improvement initiatives for firms such as Novartis, Schering Plough, Human Genome Sciences, Boehringer-Ingelheim and Kraft Foods. Prior to his consulting career he spent 24 years at the DuPont Company in a variety of assignments including pharmaceutical clinical trial design and analysis. He has developed and applied process design, improvement, monitoring and control methodologies for more than 30 years.
His recent application and research on QbD has produced eight articles on use of QbD in Pharma and Biotech. He has also coauthored 2 books on the methods and tools of QbD and speaks regularly at conferences and meetings on the subject. He is a frequent speaker and has published 5 books and more than 300 papers in the fields of performance improvement, quality, management, and statistics. He is a past recipient of the Institute of Validation Technology Speaker of the Year Award.
- 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