How to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing

Start Date : June 12, 2018
End Date : June 13, 2018
Time : 9:00 am to6:00 pm

Phone : 800-447-9407
Email : globalcompliancepanel@gmail.com

Location :
DoubleTree by Hilton Houston Intercontinental Airport 15747 JFK Blvd Houston, TX 77032

Website

Description

Course “Applied Statistics, with Emphasis on Verification, Validation, Sample Size, and Risk Management, in R&D, Manufacturing, and QA/QC” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

 

Overview:

The 2-day seminar explains how to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows:

Why should you attend:

Almost all design and/or manufacturing companies evaluate product and processes either to manage risks, to validate processes, to establish product/process specifications, to QC to such specifications, and/or to monitor compliance to such specifications.

The various statistical methods used to support such activities can be intimidating. If used incorrectly or inappropriately, statistical methods can result in new products being launched that should have been kept in R&D; or, conversely, new products not being launched that, if analyzed correctly, would have met all requirements. In QC, mistakenly chosen sample sizes and inappropriate statistical methods may result in purchased product being rejected that should have passed, and vice-versa.

This seminar provides a practical approach to understanding how to interpret and use more than just a standard tool-box of statistical methods; topics include: Confidence intervals, t-tests, Normal K-tables, Normality tests, Confidence/reliability calculations, Reliability plotting (for extremely non-normal data), AQL sampling plans, Metrology (i.e., statistical analysis of measurement uncertainty ), and Statistical Process Control. Without a clear understanding and correct implementation of such methods, a company risks not only significantly increasing its complaint rates, scrap rates, and time-to-market, but also risks significantly reducing its product and service quality, its customer satisfaction levels, and its profit margins.


Areas Covered in the Session


Who will benefit:

Agenda:

Day 1 Schedule


Lecture 1:

Regulatory Requirements


Lecture 2:

Vocabulary and Concepts


Lecture 3:

Confidence Intervals (attribute and variables data)


Lecture 4:

Normality Tests and Normality Transformations


Lecture 5:

Statistical Process Control (with focus on XbarR charts)


Lecture 6:

Confidence/Reliability calculations for Proportions


Lecture 7:

Confidence/Reliability calculations for Normally distributed data (K-tables)


Lecture 8:

Process Capability Indices calculations(Cp, Cpk, Pp, Ppk)

Day 2 Schedule


Lecture 1:

Confidence/Reliability calculations using Reliability Plotting (e.g., for non-normal data and/or censored studies)


Lecture 2:

Confidence/Reliability calculations for MTTF and MTBF (this typically applies only to electronic equipment)


Lecture 3:

Statistical Significance: t-Tests and related “power” estimations


Lecture 4:

Metrology (Gage R&R, Correlation, Linearity, Bias , and Uncertainty Budgets)


Lecture 5:

QC Sampling Plans (C=0 and Z1.4 attribute AQL plans, and alternatives to such plans), including OC curves, AQL vs. LQL/LTPD, AOQL, and calculation of acceptance rates.


Lecture 6:

Statistically valid statements for use in reports


Lecture 7:

Summary and Implementation Recommendations

Speaker

John N. Zorich

Statistical Consultant & Trainer, Ohlone College & SV Polytechnic 

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, world-wide.

 

Location:  Houston, TX Date: June 12th & 13th, 2018 and Time: 9:00 AM to 6:00 PM

Venue:  DoubleTree by Hilton Houston Intercontinental Airport 15747 JFK Blvd Houston, TX 77032

 

Price:

Price: $1,295.00 (Seminar Fee for One Delegate)

Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*

Register now and save $200. (Early Bird)

Until May 10, Early Bird Price: $1,295.00 From May 11 to June 10, Regular Price: $1,495.00

Sponsorship Program benefits for “Biostatistics for Non-Statistician” seminar

For More Informationhttps://www.globalcompliancepanel.com/control/sponsorship 

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com  

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link – https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901720SEMINAR?SEO

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Registration Info

https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901720SEMINAR?meetings4docs_june_2018_seo

Contact the Organizer

Organized by

Organized by globalcompliancepanel

NetZealous LLC DBA GlobalCompliancePanel ,
161 Mission Falls Lane,suite 216

The 2-day seminar explains how to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry

Tel: 8004479407
Mobile: 8004479407
Email: globalcompliancepanel@gmail.com
Website: https://www.globalcompliancepanel.com


Event Categories: Physical Medicine.

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