Falls Church, VA (PRWEB)
September 21, 2017
Process Capability Indices for Medical Device Manufacturers
**An FDAnews Webinar**
Sept. 26, 2017 — 1:30 p.m. – 3:00 p.m. ET
Quality in device manufacturing is an exacting business. It’s easy to get things wrong, run afoul of The Quality System Regulation (§820.250), and Devicemakers find themselves staring at a warning letter.
One of the trickiest aspects is calculating process capability indices using data from Statistical Process Control (SPC), predominantly x-bar and R charts. Master that and Devicemakers are well on their way to cleaner inspections.
FDAnews has invited top-rated presenter Dan O’Leary to show them how.
In 90 thorough, detailed minutes of lecture plus demonstration, Mr. O’Leary breaks down the process step by step. Attendees will gain understanding of:
The difference between variables data and attributes data
- The concept of process variability and its common metrics
- How to estimate process parameters from common SPC charts such as x-bar & R
- How to apply definitions of common capability indices such as Cp, Cpk, Pp, and Ppk
- Valid statistical techniques in the context of FDA’s QSR
- How to apply this information to manufacturing processes
- And much more!
Bonus: A summary of statistical process control methods and their related process control indices, including all necessary formulas and constants.
QSR requires, where appropriate, procedures for valid statistical techniques to establish, control and verify process capability acceptability. This presentation provides the information manufacturers need to develop procedures that improve the quality system and keep FDA inspectors happy.
Meet the Presenter:
Dan O’Leary, President, Ombu Enterprises LLC, is an expert on analytic skills and systems approaches in operations management. A top-rated presenter, Mr. O’Leary boasts 30+ years’ experience in quality, operations and program management in regulated industries including medical devices, clinical labs, aviation and defense. He is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in…