John N. Zorich, a senior consultant for the medical device manufacturing industry, will be the Speaker at a webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on June 11. This webinar will be the topic, “Better Alternatives to Sampling Plans”. Description: The webinar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics, especially in regards to Sampling Plans. The pros and cons of the two most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product. The advantages of "confidence/reliability" calculations are explained. Such calculations are demonstrated for Attribute data (pass/fail, yes/no data) as well as for variables data (i.e., measurements). If variables data is "Normally distributed" the calculations are extremely simple. The webinar explains how to handle "non-Normal" data, and provides the methods, formulas, and tools to handle such situations. The webinar ends with a discussion of how one OEM manufacturer has implemented "confidence/reliability" calculations instead of AQL sampling plans for all of its clients. And suggestions are given for how to use "confidence/reliability" QC specifications instead of "AQL" QC specifications. The use of "reliability plotting" for assessing product reliability during R&D is also discussed. The speaker will talk on the following topics during this session: • AQL and LQL sampling plans • OC Curves • AOQL • ANSI Z1.4 • Squeglia's C=0 • Confidence/Reliability calculations for o Attribute data o Normally-distributed variables data o Non-Normal data • Transformations to Normality • K-tables • Normal Probability Plot • Reliability Plotting ----------------------------------------------------------------------------------------------------------------- When: June 11, 10:00 AM PST | 01:00 PM EST ----------------------------------------------------------------------------------------------------------------- By whom: John N. 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, worldwide. ----------------------------------------------------------------------------------------------------------------- For whom: The webinar will benefit o QA/QC Supervisor o Process Engineer o Manufacturing Engineer o QC/QC Technician o Manufacturing Technician o R&D Engineer ---------------------------------------------------------------------------------------------------------------- Duration: 90 minutes ----------------------------------------------------------------------------------------------------------------- To enroll for this webinar, contact This email address is being protected from spambots. You need JavaScript enabled to view it. Ph: 800-447-9407 Fax: 302-288-6884

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