Recent global financial challenges have brought about immense changes to the Pharmaceutical and Biotech industries. In the interest to speed up development and improve their operations for companies the FDA is promoting the use of the Quality-by-Design (QbD) approach. 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 will provide you with some real-world and valuable 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 session includes convenient methods for making power calculations for experimental design. This webinar will use pharmaceutical and biotech case studies and examples to introduce and illustrate concepts and methods.
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
- Supply Chain Professionals
- Accounting Professionals
Course Director: 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.