Ronald D. Snee
President and Founder at 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.

Upcoming Webinar
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Recorded Webinar
Sampling - How Large a Sample Do I Need? Determining the Right Size for Accurate, Cost Effective Results
The Pharmaceutical and Biotech industries are going through tremendous changes that have been increased by the recent global financial challenges. The FDA is promoting the use of Quality-by-Design (QbD) as an approach for helping companies speed up development and improve their operations. In addition the FDAs new process validation guidance promotes continued process verification. Sampling is an essential element of both process and product development and continued process verification. This raises the question "How Large a Sample Do I Need?"
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Process Risk Management Strategies - Reduce Risk and COGS While Improving Yield and Compliance
A critical source of risk to patients using pharmaceuticals to improve their health is inadequate design and control of the processes that manufactured the drugs. R&D, Manufacturing, Quality Assurance, Quality Control and Regulatory Affairs play a critical role in reducing risk associated with poorly operating processes. The ICH guidance documents Q8, Q9 and Q10 has heightened awareness in the pharmaceutical and biotech industries of the need to reduce process risk. This trend is also being promoted by the FDA as an approach to process improvement with the benefit of enhanced regulatory flexibility. But the questions remain: What does it mean to reduce risk, to manage risk, and how do you do it? Fortunately we have a lot of experience on which to draw.
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Conducting, Documenting and Reporting Statistical Analysis
Use of statistics has been part of the FDA's guidance and regulations for many years. Use of statistical tools is an integral part of the Quality by Design and Process Analytical Technology promoted by the FDA. The Jan 2011 FDA process validation guidance has statistical thinking and methods at its core. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. Even with this long history, the use of statistics seems to be a source of uncertainty and anxiety for many.
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Implementing a Metrics Program - Uncovering and Overcoming the Challenges
Recently the FDA released their draft guidance for industry entitled "Request for Quality Metrics". Much discussion of quality metrics has ensued regarding this guidance and its elements. This presentation provides an integrated view of the aspects of Quality Metrics including the required supporting quality culture.
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Improving Process Stability and Capability - Tips, Traps and Guidance
Learn the "What", "Why" and "How" of improving process capability and stability. Topics discussed include: FDA Guidance, pharma and biotech industry experience, pitfalls to avoid, sampling procedures and data quality.
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Solving Statistical Mysteries - What Does the FDA Want?
This webinar provides an overview of what it appears the FDA is looking for in the use statistics by taking illustrative examples from warning letters and industry experiences and approaches that have worked in a variety of situations.Use of statistics has been part of the FDA's guidance and regulations for many years. Use of statistical tools is an integral part of the Jan 2011 FDA Process Validation Guidance. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. Even with this long history, the use of statistics seems to be a source of uncertainty and anxiety for many.
Recorded Session Get life time access for one participant with download option!

How to Detect Lack of Data Integrity
This webinar will help attendees obtain an understanding of the regulatory expectations for Data Integrity. The information provided at the webinar will enable the attendees to review practices at their own site, identify gaps relative to current regulatory expectations and utilize the advice provided during the webinar to address the identified issues.
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Process Monitoring and Control - A Quality by Design Approach
The QbD "Design Space" concept has been given much attention by pharmaceutical 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.
Recorded Session Get life time access for one participant with download option!

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