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Confidence-Reliability Calculations and Statistically Valid Sample Sizes

Event Details

Confidence-Reliability Calculations and Statistically Valid Sample Sizes

Time: March 18, 2020 from 10am to 1pm
Location: Online
Street: 39658 Mission Boulevard, Fremont, CA 94539, USA.
City/Town: United States
Website or Map: https://www.compliance4all.co…
Phone: +1-800-447-9407
Event Type: online, event
Organized By: Compliance4all
Latest Activity: Jan 6

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Event Description

Overview:

The webinar 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 webinar. A final discussion is provided on how to introduce the methods into a company.

Why should you attend: 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).



Areas Covered in the Session:

  • 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:
  • QA/QC Supervisor
  • Process Engineer
  • Manufacturing Engineer
  • QC/QC Technician
  • Manufacturing Technician
  • R&D Engineer

Speaker Profile
John N. Zorich has spent almost 40 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 next 15 years were as a consultant in the areas of QA/QC and Statistics. These last few years were as a trainer and consultant in the area of Applied Statistics only. 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.

Event link:

https://www.compliance4all.com/webinar/-502878LIVE?channel=medtechiq_2020_SEO

Contact Info

Net zealous LLC, DBA -Compliance4all

Email: support@compliance4All.com

Phone: +1-800-447-9407

Website: https://www.compliance4all.com/

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