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 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 Should Attend:
Department Managers
Quality Engineers
Research and Development Scientists
Biologists and Microbiologists
Process and Manufacturing Engineers
Quality Assurance Personnel
Executives
Supply Chain Professionals
Accounting Professionals