Live webcast Process Capability Indices for Medical Device Manufacturers

Website https://compliance2go.com/product/?pid=CP2014-428 | Edit Freely

Category Medical Device

Deadline: March 22, 2015 | Date: March 23, 2015

Venue/Country: Online, U.S.A

Updated: 2015-03-03 16:44:02 (GMT+9)

Call For Papers - CFP

Manufacturing processes for medical devices involve statistical methods. Process capability analysis examines the inherent variability in a process including the statistical distribution of the process output. When the measurement uses variables data, process variability is the “spread” of a process in statistical control. When the measurement involves attributes data, process capability is often the proportion of nonconforming units.

Process capability uses an index that relates process variability and product specifications. This webinar explains the underlying statistics of the most commonly used capability indices. In particular, the webinar explains how to use data from Statistical Process Control (SPC), particularly x-bar and R charts, to calculate these process capability indices.

With an understanding of process capability indices, the topic moves to medical device applications. The webinar illustrates applications of process capability indices in both FDA QSR and ISO 13485 systems using both examples and FDA Warning Letters to illustrate the issues.

Why Should You Attend

Medical device manufacturers need a solid understanding of process control and statistical methods. One major component is process capability indices. This webinar provides practical information on the use, and abuse, of these common metrics.

Areas Covered In the Webinar

The difference between variables data and attributes data

The concept of process variability and its common metrics

Estimating process parameters from common SPC charts such as x-bar & R

Definitions of common capability indices such as Cp, Cpk, Pp, and Ppk

Determining valid statistical techniques in the context of FDA QSR

Applications to medical device manufacturing processes

Who will benefit

People in the following roles can especially benefit from the knowledge in this webinar:

Quality Managers

Quality Engineers

Process Engineers

Production Managers

Production Supervisors

Reliability Engineers

Validation engineers

Webinar Includes:

Q/A Session with the Expert to ask your question

Copy of PowerPoint slides (PDF print only)

90 Minutes Live Presentation

Certificate of Attendance