The seminar begins with a discussion of relevant regulatory requirements, as motivation for calculating "confidence/reliability". Then, some vocabulary and basic concepts are discussed.

1. Webinar On Webinar On Process Capability
Analysis using Confidence/Reliability
Calculations
Presented By John N. Zorich
Contact Us: 416-915-4458
Hosting By
Compliance Trainings
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Thursday, April 9, 2015 at 13:00 Hrs

2. Contact Us: 416-915-4458
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Webinar Description:
Process Capability Analysis using Confidence/Reliability Calculations
All manufacturing and development companies perform testing and/or
inspections that involve concluding whether or not a product or lot is acceptable
vs. design or QC specifications. Such test/inspections may occur during design
verification/validation or during incoming or final QC.
The most informative method for analyzing the data that results from such
activities is the calculation of the product's or lot's "reliability" at a chosen
"confidence" level (where "reliability" means "in-specification"). Such a method
produces information that is more valuable than simply that the given product or
lot "passed" (as is the case when "AQL Attribute Sampling Plans" are used) or a %
in-specification statement without any corresponding confidence statement (as is
the case with AQL Variables Sampling Plans and with Process Capability
calculations).
The output of a "Confidence/Reliability" calculation is a definitive statement that
the given product or lot has a specific % in-specification, which conclusion we can
state with a specific level of confidence (e.g., 95% confidence of 99% reliability, or
90% confident of 93% reliability").
Product Id MD1277
Category Medical Devices
Scheduled On Thursday, April 9, 2015 at 13:00 Hrs
Duration 90 Minutes
Speaker John N. Zorich
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3. Areas Covered in the Session :
The seminar begins with a discussion of relevant regulatory requirements, as
motivation for calculating "confidence/reliability". Then, some vocabulary and
basic concepts are discussed.
Next, detailed descriptions are given for how to calculate confidence/reliability
for data that is either pass/fail (i.e., "attribute" data), normally-distributed
measurement data, non-normally distributed measurement data that can be
transformed into normality, or non-normally distributed measurement data that
cannot be transformed into normality. Spreadsheets are shown as examples of
how to implement the methods described in the seminar. A final discussion is
provided on how to introduce the methods into a company.
All the above is captured in these bullet points:
Regulatory Requirements
Vocabulary and Concepts
Attribute Data
Normal Data
Normal Probability Plotting
Non-Normal Data that can be normalized
Reliability Plotting (for data that cannot be normalized)
Implementation Recommendations
Who will Benefit
A must attend webinar for all
QA / QC Supervisors
Process Engineers
Manufacturing Enginee
QA / QC Technicians
Manufacturing Technicians
R&D Engineers

4. 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 R&D,
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.

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