Statistical Process Control: FDA and ISO Requirements to Control and Monitor Production Process

3 February 2015, Fremont, United States


Introduction
SPC is a statistical tool that objectively identifies when it is worthwhile to perform a formal investigation of manufacturing variation, in order to identify and reduce its cause. SPC continually adjusts its sensitivity in order to ensure that such investigations are performed only when there is a reasonable chance of identifying causes of variation. SPC also provides information that can be used to estimate what % of items is being produced "in specification".

Why should you attend: All companies want to improve the quality of their products. Attempts to improve product quality need to be structured in such a way that they have a reasonable chance of success and the cost/benefit ratio is appropriate. The most successful method available for such endeavors is called SPC (statistical process control). SPC can also be used to meet ISO requirements for "continual improvement" as well as FDA requirements to "control and monitor production processes". SPC can even be used to monitor complaint rates, to determine if there has been a "significant" increase in complaints, which would therefore trigger an MDD "vigilance report" and/or an FDA MDR submission.

Areas Covered in the Session:

Definition of relevant terms
Types of control charts
Calculation of control limits for an XbarR chart
Rules for detecting "out of control"
Sampling
Process Capability Indices (Cp, Cpk, Pp, Ppk)
SPC Program implementation


Speakers
Venue
online event

online event , NetZealous LLC, 161 Mission Falls Lane , Suite 216, California, Fremont, 94539, United States

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Compliance4All, the ultimate continuing professional education provider offers you regulatory and compliance trainings from the industry's leading experts, but with one crucial difference -the cost. Compliance4All's objective is to be a platform that provides regulatory and compliance trainings with all the class and features that come with these trainings, at a lower price. Compliance4All seeks to make regulatory and compliance trainings low-hanging fruits.
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