Monitoring Product Quality, Process Performance and Enabling Continued Process Verification – A Systems Approach

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 120 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 120 mins Live Webinar

"Ron Snee is Founder and President of Snee Associates, LLC a firm dedicated to successful implementation of process and organizational improvement initiatives"

Disciplined and structured QbD approach to achieve this objective

Description

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

Areas Covered

•       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 will 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

Industries who can attend

This 120-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Speaker Profile

Ron Snee

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.

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