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Webinar Price Details

Overview

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

"How Large a Sample Do I Need?"

Methods for determining appropriate sample sizes in raw materials acceptance, finished product release, process and product development experimentation and process monitoring for process stability and capability is discussed. A comparison is made of the square root (n)+1 sampling rule with the ANSI Z1.4 sampling system for process monitoring including incoming raw materials, in-process manufacturing and finished product.

The value of a systems approach to sampling and practical tips, traps and guideline for sampling is discussed. The presentation includes portable methods for making power calculations for experimental design. The concepts and methods involved are introduced and illustrated with pharmaceutical and biotech case studies and examples.

Why you should Attend

What a Participant will learn:

  • Principles for developing useful sampling plans and procedures
  • When “Square Root (n)+1” is a valid sampling plan
  • Creating a process sampling system using ANSI Z1.4 Sampling Plans
  • Sampling plans for monitoring process stability and capability
  • Practical power calculation procedures for determining appropriate experiment size
  • Plans for sampling tanks and blenders
  • How to use sampling data to get early warning of impending process problems
  • Tips, Traps and guidelines for developing successful sampling plans

Areas Covered in the Session

  • Principles for developing useful sampling plans and procedures
  • When “Square Root (n)+1” is a valid sampling plan
  • Creating a process sampling system using ANSI Z1.4 Sampling Plans
  • Sampling plans for monitoring process stability and capability
  • Practical power calculation procedures for determining appropriate experiment size
  • Plans for sampling tanks and blenders
  • How to use sampling data to get early warning of impending process problems
  • Tips, Traps and guidelines for developing successful sampling plans

Who Will Benefit

  • 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
  • Those who desire to learn the fundamentals of sampling  

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.