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

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Description:

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?”

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.

Areas to be Covered:

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 Engineers
Research and Development Scientists
Biologists and Microbiologists
Process and Manufacturing Engineers
Quality Assurance Personnel
Executives
Supply Chain Professionals
Accounting Professionals

Dr. Ronald D. Snee

Ronald D. Snee, PhD, is Founder and President of Snee Associates, LLC. He provides guidance to senior executives in their pursuit of improved business performance using Lean Six Sigma, Quality by Design (QbD), and other data-based improvement approaches that produce bottom line results. He has played a leadership role in 32 major improvement initiatives for firms such as Novartis, Human Genome Sciences, and Kraft Foods.

Ron also serves as Adjunct Professor in the Temple University School of Pharmacy and Rutgers University Pharmaceutical Engineering Program. Prior to entering the consulting field he worked at DuPont for 24 years in a variety of assignments including pharmaceuticals.

He received his BA from Washington and Jefferson College and MS and PhD degrees from Rutgers University.

Ron in an Honorary Member of the American Society for Quality and has been awarded the ASQ’s Shewhart, Grant and Distinguished Service Medals. Other awards and honors include the American Statistical Association’s Deming Lecture, W. J. Dixon Statistical Consulting Excellence and Gerald J. Hahn Quality and Productivity Achievement Awards. He is a frequent speaker and has published six 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’s Speaker of the Year Award.

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  • Presentation Handout in .pdf format
  • Presentation from the Speaker
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  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
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