Statistical Analysis – Planning, Conducting, Documenting and Reporting

Use of statistics has been part of the FDA’s guidance and regulations for many years. Recent uses include Quality by Design, Process Analytical Technology and the 2011 FDA Process Validation Guidance. Even with this long history, the use of statistics seems to be a source of uncertainty and anxiety for many.

This webinar addresses how to effectively use statistical thinking and methods by providing a process for planning, conducting, documenting and reporting statistical analyses. This “process” includes: the critical steps involved, how to use visualization to analyze and report results, the most frequently used statistical tools and the most useful graphical and data visualization methods. Roadmaps are provided, critical steps are identified and illustrative examples and case studies are provided.

Areas Covered in the Session :

  • Today’s Reality: FDA Guidance Regarding:
    • Quality by Design and Process Validation
    • Examples of Recommended use and reporting of Statistical Thinking and Methods
  • 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
  • “Process” of Planning, Conducting, Documenting and Reporting Statistical Analyses
  • Tips, Traps and Recommendations
Who Will Benefit:

  • Quality Assurance Departments
  • Regulatory Affairs
  • Quality Departments
  • Research & Development Scientists
  • Manufacturing Departments
  • Quality Control Lab Personnel
  • Engineering Departments
  • Production Departments
  • Biologists and Microbiologists
  • Chemists and Chemical Engineers
  • Process Engineers
  • Everyone who collects, analyzes and reports data as part of their work responsibilities

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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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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.