How Large a Sample Do I Need? Pharmaceutical, Biotech Webinar

Ron Snee

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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 Should You Attend:

In this webinar, you 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

The Pharmaceutical and Biotech industries are going through tremendous changes that have been increased by the recent global financial challenges. The FDA is promoting the use of Quality-by-Design (QbD) as an approach for helping companies speed up development and improve their operations. In addition, the FDAs new Process Validation Guidance promotes Continued Process Verification. Sampling is an essential element of both process and product development and continued process verification. This raises the question “How Large a Sample Do I Need?”

Areas Covered in the Webinar:

  • 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:

Pharma and Biotech personnel including:

  • 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

Free Materials:

Copies of slides of presentation

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Speaker: 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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