Method Validation – Utilizing Quality by Design (QbD) and Risk in Implementation

Pharmaceutical industry is experiencing a growing need to improve performance driven by global competition and the increasing impact of information technology. FDA’s Process Validation Guidance calls for continued process verification which applies to both manufacturing and measurement processes. How to go about this improvement in a systematic, focused and sustainable manner is the question. Fortunately a world-class body of improvement technology exists known as Quality by Design (QbD); a science and data-based approach that builds quality into products and processes during development, validation and operations.

A characteristic of good science is good data. Quality data are arguably more important today than ever before. Using a series of case studies and examples it will be shown how QbD can be integrated into a holistic approach that can be used to effectively design and improve laboratory processes enabling prompt, successful method validation. Methods discussed in this session include assessment of method design, repeatability and reproducibility, improving method robustness and measurement process control.

Methods for assessing that amount of product variation that can be attributed to the manufacturing process, sampling procedures and test method are also presented. The concepts and methods involved will be introduced and illustrated with pharmaceutical and biotech case studies and examples.

Areas Covered in the Session :

Participants in the webinar will learn how to improve test method performance by:

• Rapid design and development of test methods using statistical design of experiments
• Improving measurement quality using Gage Repeatability and Reproducibility studies
• Developing measurement systems that are robust to variations in method use
• Controlling measurement variation by using control samples and statistical process control techniques
• Identifying how much of the total variation is due to the manufacturing process, the sampling procedure and the test method

Who Should Attend:

• Executives and Managers engaged in Pharmaceutical and Biotech Research and Development
• Quality Assurance Personnel
• Regulatory Affairs Professionals
• Test Method Development and Validation Personnel
• Quality Engineers
• Process and Manufacturing Engineers
• Research and Development Scientists
• Operations Excellence Professionals
• Biologists and Microbiologists
• Chemists and Chemical Engineers
• Anyone with a desire to learn the fundamentals of methodical performance improvement

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.