Process Capability Indices for Medical Device Manufacturers
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Website https://compliance2go.com/product/?pid=CP2014-428 |
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Category Medical Device
Deadline: March 23, 2015 | Date: March 23, 2015
Venue/Country: Online, U.S.A
Updated: 2015-02-27 17:37:41 (GMT+9)
Call For Papers - CFP
DESCRIPTIONManufacturing 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 AttendMedical 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 WebinarThe difference between variables data and attributes dataThe concept of process variability and its common metricsEstimating process parameters from common SPC charts such as x-bar & RDefinitions of common capability indices such as Cp, Cpk, Pp, and PpkDetermining valid statistical techniques in the context of FDA QSRApplications to medical device manufacturing processesWho will benefitPeople in the following roles can especially benefit from the knowledge in this webinar:Quality ManagersQuality EngineersProcess EngineersProduction ManagersProduction SupervisorsReliability EngineersValidation engineersWebinar Includes:Q/A Session with the Expert to ask your questionCopy of PowerPoint slides (PDF print only)90 Minutes Live PresentationCertificate of Attendance
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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