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.

Below strategies and the associated guiding principles will be discussed and illustrated with examples and case studies from the pharma and biotech industries. The focus is on reducing risk to reducing cost of goods sold (COGS) while improving process yield and compliance. The discussion also addresses how to make the use of process risk analysis and risk management an integral part of your process management systems, methods and tools.

Areas Covered in the Session :

  • Utilizing the relationship between process variation, process understanding, process risk and compliance
  • Using a systematic approach to identify the critical few variables that have a major impact on the process: Raw materials, process steps, and process variables and uncontrollable (environmental) variables
  • Increasing process stability and capability
  • Creating a process control strategy
  • Robustness studies of the product and process
  • Improvement of measurement performance including improved control and robustness of analytical methods
Who Should Attend:

  • Product Development Scientists
  • Process Development Scientists and Managers
  • Manufacturing Leaders, Staff and Stakeholders
  • Regulatory Affairs Leaders
  • Manufacturing Engineers
  • Quality Assurance Personnel
  • Quality Improvement Engineers
  • Quality Control Personnel
  • Test Method Developers


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.

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  • Presentation Handout in .pdf format
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