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.
The QbD “Design Space” concept has been given much attention by pharma and biotech industries but much less attention has been given to implementation of “process control” systems needed to keep the process in-control and consistently producing quality product. Process data are routinely analyzed at two levels to assess process stability and capability. During the production of each batch data are collected by the process operators and Quality Control to assure within batch stability and capability and that appropriate actions are taken when needed. On a monthly or quarterly basis, the batch-to-batch variation in product parameters is analyzed to assess the long-term stability and capability of the process. This system is illustrated and discussed in detail. Critical questions and challenges are identified. Connections of this system to process robustness are also addressed.
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 Departments
- Regulatory Affairs Departments
- Quality Control Lab Personnel
- Quality Engineers
- Research and Development Departments
- Biologists and Microbiologists
- Chemists and Chemical Engineers
Course Director: DR. RONALD D. SNEE
Ronald D. Snee, PhD, is Founder and President of Snee Associates, LLC. He provides guidance to senior executives in their pursuit of improved business performance using Lean Six Sigma, Quality by Design (QbD), and other data-based improvement approaches that produce bottom line results. He has played a leadership role in 32 major improvement initiatives for firms such as Novartis, Human Genome Sciences, and Kraft Foods.
Ron also serves as Adjunct Professor in the Temple University School of Pharmacy and Rutgers University Pharmaceutical Engineering Program. Prior to entering the consulting field he worked at DuPont for 24 years in a variety of assignments including pharmaceuticals.
He received his BA from Washington and Jefferson College and MS and PhD degrees from Rutgers University.
Ron in an Honorary Member of the American Society for Quality and has been awarded the ASQ’s Shewhart, Grant and Distinguished Service Medals. Other awards and honors include the American Statistical Association’s Deming Lecture, W. J. Dixon Statistical Consulting Excellence and Gerald J. Hahn Quality and Productivity Achievement Awards. He is a frequent speaker and has published six 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’s Speaker of the Year Award.