Sampling - How Large a Sample Do I Need? Determining the Right Size for Accurate, Cost Effective Results
Duration: 90 Minutes
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?"
Objectives of the Presentation
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
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Download Agenda- 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
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