Solving Statistical Mysteries - What Does FDA Want?


Instructor: Ron Snee
Product ID: 706371
Training Level: Basic

  • Duration: 90 Min

This webinar provides some practical and useful answers to the question "What Kind of Statistical Methods and Tools Does the FDA Want Pharma to Use?"

FDA’s guidances and regulations have emphasized the use of statistics for many years. Statistical thinking and methods 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. This presentation provides an overview of what it appears the FDA is looking for in the use statistics including examples and recommended approaches.

Last Recorded Date: Jul-2020


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Read Frequently Asked Questions

Why Should You Attend:

What a Participant will learn:

  • 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

Areas Covered in the Webinar:

  • What the FDA is looking for in the use 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

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

From the Pharma and Biotech Industries

Free Materials:

  • Copies of slides of presentation
Instructor Profile:
Ron Snee

Ron Snee
Founder and President, Snee Associates

Ron 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, 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 pharmaceuticals.

While at DuPont he got involved in developing mixture and formulation systems which lead to the creation of several seminal advances for the effective design and analysis of mixture experiments. Snee has worked in the field for more than 40 years. His accumulated learnings have resulted in the recent book Strategies for Formulations Development – A Step-by-Step approach using JMP software, published by SAS Books, Cary, NC 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.

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