Sampling - How Large a Sample Do I Need? Determining the Right Size for Accurate, Cost Effective Results

Duration: 90 Minutes
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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?"
Sampling Plans
Instructor: Ronald D. Snee
Product ID: 506454
Objectives of the Presentation
  • 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
Why Should you Attend
This webinar provides some practical and useful answers to this question. 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.

Who will Benefit
  • Department Managers
  • Quality Engineers
  • Research and Development Scientists
  • Biologists and Microbiologists
  • Process and Manufacturing Engineers
  • Quality Assurance Personnel
  • Executives
  • Supply Chain Professionals
  • Accounting Professionals
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Instructor Profile:
Ron Snee is the Founder and President of Snee Associates, a firm dedicated to 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 approaches that produce bottom line results. He has played a leadership role in 32 major improvement initiatives for firms such as Novartis, Schering Plough, Human Genome Sciences, Boehringer-Ingelheim and Kraft Foods. Prior to his consulting career he spent 24 years at the DuPont Company in a variety of assignments including pharmaceutical clinical trial design and analysis. He has developed and applied process design, improvement, monitoring and control methodologies for more than 30 years.

His recent application and research on QbD has produced eight articles on use of QbD in Pharma and Biotech. He has also coauthored 2 books on the methods and tools of QbD and speaks regularly at conferences and meetings on the subject. He is a frequent speaker and has published 5 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 Technology Speaker of the Year Award.


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