Online Webinar 2019 - 2 Hrs Live Webinar Monitoring Product Quality, Process Performance and Enabling Continued Process Verification – A Systems Approach

Session Highlights
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 would benefit?
Executives
Department managers
Quality Engineers
Research and Development Scientists
Biologists and Microbiologists
Chemists and Chemical Engineers
Process and Manufacturing Engineers
Quality Assurance Personnel
Suppliers to Lean Six Sigma companies
Supply Chain Professionals
Accounting Professionals
Anyone with a desire to learn the fundamentals of methodical performance improvement
Overview
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. 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. 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 QbD approach to achieve this objective. 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 between this system process robustness are also addressed
Speaker
Ron Snee is Founder and President of Snee Associates, LLC 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 teaches QbD and related methodologies as an Adjunct Professor at Temple University School of Pharmacy. Ron received his BA from Washington and Jefferson College and MS and PhD degrees from Rutgers University.