Webinar On Statistical Process Control (SPC) (1)

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Statistical Process Control (SPC)
Product Id
FDB1270 
Category
Food, Drugs Biologics
Scheduled On
Tuesday, June 10, 2014 at 1300 Hrs
Duration
90 Minutes
Speaker
John N. Zorich
To register for this webinar please visit our
website www.compliancetrainings.com
Webinar Description
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. Manufacturing
involves an attempt to produce items that as
closely as possible meet design specifications
(e.g., size, strength, etc.). However, all
production processes exhibit variation --- that
is, no two items are identical. What method can
we use to reduce such variation? The classic and
still most widely used method is called SPC or
"statistical process control". 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".


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

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Who Will Benefit

• QA/QC Supervisors
• Process Engineers
• Manufacturing Engineers
• QC/QC Technicians
• Manufacturing Technicians
• RD Engineers

Speaker Profile
John Zorich has spent 35 years in the medical
device manufacturing industry the first 20 years
were as a "regular" employee in the areas of RD,
Manufacturing, QA/QC, and Regulatory the last 15
years were as consultant in the areas of QA/QC
and Statistics. His consulting clients in the
area of statistics have included numerous
start-ups as well as large corporations such as
Boston Scientific, Novellus, and Siemens Medical.
His experience as an instructor in statistics
includes having given 3-day workshop/seminars for
the past several years at Ohlone College (San
Jose CA), 1-day training workshops in SPC for
Silicon Valley Polytechnic Institute (San Jose
CA) for several years, several 3-day courses for
ASQ Biomedical, numerous seminars at ASQ meetings
and conferences, and half-day seminars for
numerous private clients. He creates and sells
formally-validated statistical application
spreadsheets that have been purchased by more
than 75 companies, world-wide.

To register our webinar visit our website
www.compliancetrainings.com