This Process Capability Analysis training will present the concepts of process capability and the setting of data driven specifications including real time measurements. We will look at short term and long term process capability.
The current buzz in the biological manufacturing is Process Analytical Technology (PAT). This webinar presents the concepts of process capability and the setting of data driven specifications including real time measurements. We will look at short term and long term process capability. Different capability indices will be presented with examples showing how the indices relate to the PAT.
Areas Covered in the seminar:
- Introduction to Capability Analysis
- Capability Indices
- Calculating Sigma
- What is PAT?
- How can you use Process Capability to address PAT?
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
- Analytical Method Scientists
- QC and QA personnel
- Quality Auditors
Instructor Profile
Steven Walfish is the founder and President of Statistical Outsourcing Services. He brings over 17 years of industrial experience providing statistical solutions to complex business problems. Mr. Walfish was Senior Manager Biostatistics, Nonclinical at Human Genome Sciences in Rockville MD. Mr. Walfish has held positions with PricewaterhouseCoopers, Chiron Diagnostics and Johnson & Johnson. 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.