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.

Learning Objectives :

To have a complete understanding of what the FDA is requiring pharma and biotech companies to do regarding the use of statistical thinking and methods and what statistical concepts, methods and tools that can be used to satisfy the FDA requirements.

Key Take Away :

• Awareness and understanding of what the FDA is looking for in the use statistics
• Understanding of what works and doesn’t work
• Obtain information and ideas on approaches that have worked in a variety of situations

Areas Covered in the Session :

Today’s Reality: FDA Guidance Regarding:

• Quality by Design
• Continued Process Verification
• Test Method Development
• FDA Guidance’s – Examples of Recommended use of Statistical Thinking and Methods
• Tools, Methods and Personnel
• What is the Appropriate Documentation?
• What’s the FDA Looking for?
• Right Process Measurement, Data, Tools and Methods and Interpretation
• Useful Standards
• Understanding of tool usage and interpretation of results
• Tips, Traps and Recommendations

Who Should Attend:

• Executives and Managers of Pharma and Biotech Companies
• Process and Manufacturing Engineers
• Quality Assurance Personnel
• Regulatory Affairs Professionals
• Quality Control Lab Personnel
• Quality Engineers
• Research and Development Scientists
• Biologists and Microbiologists
• Chemists and Chemical Engineers

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.