Zurich, Switzerland: +41 - 43 434 80 33   |   US: (510) 962-8903   |   support@traininng.com

Webinar Price Details

Overview

This presentation provides an overview of what it appears the FDA is looking for in the use statistics including examples and recommended approaches. This discussion includes:

  • Mistakes pharma and biotech companies frequently make in the use of statistical thinking and methods
  • Most frequently used statistical tools: Control charts, capability and performance indices, design of experiments, graphical methods, etc.
  • What works and what doesn’t work
  • Information and ideas on approaches that have worked in a variety of situations
  • Problems to be on the lookout for and useful solutions
  • What are the most useful graphical and data visualization methods

Why you should Attend

This webinar provides some practical and useful answers to the question: 

"What is the FDA Looking for in the Use of Statistics?"

  • Mistakes pharma and biotech companies frequently make in the use of statistical  thinking and methods
  • Most frequently used statistical tools: Control charts, capability and performance indices,  design of experiments, graphical methods, etc.
  • What works and what doesn’t work
  • Information and ideas on approaches that have worked in a variety of situations
  • Problems to be on the lookout for and useful solutions
  • What are the most useful graphical and data visualization methods

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 Will Benefit

  • Regulatory Affairs Personnel
  • Department Managers
  • Quality Assurance Personnel
  • Quality Engineers
  • Process and Manufacturing Engineers
  • Research and Development Scientists
  • Biologists and Microbiologists
  • Chemists and Chemical Engineers
  • Supply Chain Professionals

Speaker Profile

Ronald D.Snee is Founder and President of Snee Associates, a firm dedicated to the 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, Continued Process Verification, Lean Six Sigma and other improvement approaches that produce bottom line results. Prior to his consulting career he spent 24 years at the DuPont Company in a variety of assignments including pharmaceutical development.

He has been developing and applying QbD methodologies for more than 30 years. His recent application and research on QbD has produced more than ten articles on use of QbD in Pharma and Biotech. He has also coauthored 3 books on the methods and tools of QbD and speaks regularly at conferences and meetings on the subject. He teaches QbD and related methodologies as an Adjunct Professor at Temple University School of Pharmacy and Rutgers University Pharmaceutical Engineering program.

Ron received his BA from Washington and Jefferson College and MS and PhD degrees from Rutgers University. He is an academician in the International Academy for Quality and Fellow of the American Society of Quality, American Statistical Association, and American Association for the Advancement of Science.

He is an Honorary Member of ASQ and has been awarded ASQ’s Shewhart, Grant and Distinguished service Medals, and ASA’s Deming Lecture, W. J. Dixon Consulting and Gerry Hahn Quality and Productivity Achievement Awards. He is a frequent speaker and has published 7 books and more than 330 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.