Introduction to Process Capability

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Process capability studies are necessary to evaluate the ability of the process to meet specifications. They determine of the process is on target and if the process spread is acceptable. This talk will cover calculation of process capability indices, impact of sample size, confidence intervals and capability analysis of multi-modal and non-normal data.

This webinar is valuable for understanding how process capability studies can be used to validate and represent your process. Identifying the correct methods and sample size will save time and money.

Areas to be Covered:

Metrics for Process Control
Rational sub-grouping
Assessing normality
Sample size
Dealing with non-normal data
Capability for multi-modal populations

Who will Benefit:

Research and Development
Regulatory Affairs personnel
Quality assurance personnel
Quality control personnel
Auditors and Inspectors

Steven Walfish

Steven Walfish is a Principal Statistician at Becton Dickinson (BD) in Franklin Lakes, NJ. Mr. Walfish is responsible for non-clinical statistical support for operations, quality and product development. Prior to joining BD in 2012, Mr. Walfish was a Statistician at GE Healthcare in Waukesha, WI responsible for global statistical support. Prior to joining GE Healthcare, Mr. Walfish had a statistical consulting company that provides statistical analysis and training to the FDA regulated industries. Prior to starting Statistical Outsourcing Services, Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD.

Mr. Walfish brings over 25 years of industrial expertise in the development and application of statistical methods for solving complex business issues including data collection, analysis and reporting.

Mr. Walfish has been an invited lecturer at Medical Design and Manufacturer (MD&M), Institute of Validation Technology (IVT) and Advanstar conferences. Mr. Walfish has been a speaker at ASQ Division and Section conferences. He is also an editorial board member for BioPharm International, and a regular contributor to the magazine.

Mr. Walfish is the secretary for TAG69, senior member of ASQ, a certified quality engineer and past chair of the Biomedical Division (2006-07). Mr. Walfish holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • 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