Applied Practical Statistics, with Emphasis on Verification, Validation, Sample Size, and Risk Management in R&D, Mfg. and QA/QC: 2-Day In-Person Seminar

By: John N Zorich, Statistical Consultant and Trainer, Statistical Consultant
Location :- Houston, TX | Thursday, December 5, 2019 | Friday, December 6, 2019

We need the below information to serve you better

Course Description:

Almost all design and/or manufacturing companies evaluate product and processes in order to either manage risks, validate processes, establish product/process specifications, QC to such specifications, and/or 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, they can result in deciding a new product is not ready for launch, but whose product reliability or process capability is actually very good. In QC, mistakenly chosen sample sizes and inappropriate statistical methods may result in product being rejected that should have passed, and vice-versa.

This seminar provides a practical approach to understanding how to interpret and use a standard tool-box of statistical methods, including confidence intervals, t-tests, Normal K-tables, Normality tests, Confidence/Reliability calculations, Tolerance Limits, Reliability Plotting, AQL sampling plans, measurement equipment analysis (including Gage R&R), and Statistical Process Control (including Cpk/Ppk calculations). 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.

The seminar includes a strong focus on risk-management, regulatory compliance, and sample-size determination/justification.

At the start of the course, a large suite of statistical application spreadsheets is given to all students, in order to assist them in understanding and applying the course concepts and methods after returning home. Additionally, the instructor is available indefinitely by email, free of charge, to answer short questions related to the course topics, and/or to perform statistical analysis on data-sets that are provided to him in an Excel spreadsheet (in such cases, the data should be presented as a set of numbers and their QC/Design specifications, without any explanation regarding the identity of the company’s product that generated them; therefore signing an NDA would not be necessary).

Learning Objectives:

  • How to apply “confidence” and “risk management” to virtually all statistical techniques
  • Know when to use “exact” methods rather than “approximation” methods
  • Know when to use commercial software (e.g., Minitab, StatGraphics) and when to use Excel
  • How to explain statistics to management
  • How to interpret regulatory requirements related to statistics
  • How to determine the smallest sample size needed to achieve a desired outcome.

Areas Covered :

  • Basic regulatory requirements related to statistics (for medical devices and pharmaceuticals)
  • Basic statistical concepts and vocabulary
  • Normality, Normality Tests, and Normality Transformations
  • Statistical Process Control
  • Process and Product Capability assessments including: Confidence/Reliability Calculations, Tolerance Limits, Cpk/Ppk, and Reliability Plotting
  • Statistical Significance tests (including testing for “Superiority”, “Non-inferiority”, and “TOST”)
  • Statistical Power
  • Metrology (statistical analysis of measurement uncertainty, including Gage R&R and “guard-banding”)
  • QC Sampling Plans (AQL vs. LQL vs AOQL vs. other alternatives)
  • Statistical justification for Process Validation sample sizes and the use of only 3 Lots
  • Examples of “statistically valid rationales” regarding sample sizes.


Who will Benefit:

  • R&D Manager
  • QA/QC Manager
  • Manufacturing Manager
  • R&D Engineer
  • Manufacturing Engineer
  • Process Engineer
  • Validation Engineer
  • QC/QC Technician

Course Outline

Day One (8:30 AM – 6:00 PM)
  • 08.30 AM - 08.59 AM – Registration, Meet & Greet
  • 9:00 AM -10:30 AM
    • Introduction.
    • Regulatory Requirements
      • 21CFR211
      • ISO 13485
      • IVDD
      • 21CFR820
    • Basic Statistical Concepts
      • Sample vs. Population
      • Statistic vs. Parameter
      • Law of Large Numbers
      • Binomial Distribution
      • Hypergeometric Distribution
      • Normal vs. Non-Normal Distribution
      • Central Limit Theorem
      • Standard Deviation vs. Standard Error
  • 10:30 AM-10:40 AM break
  • 10:40 AM-12:00 PM
    • Correlation Coefficients vs. Coefficients of Determination
    • Confidence Intervals (attribute and variables)
      • Attribute
      • variables
  • 12:00 PM -1:00 PM Lunch
  • 1:00 PM -2:30 PM
    • Normality Tests and Normality Transformations
    • Statistical Process Control
      • Mathematical definition of Quality
      • Common vs. Special causes of variation
      • In-control vs. Out-of-control
      • XbarR charts
      • Control chart limits vs. Specification Limits
      • Calculation of control chart limits
      • Rules for "out of control"
      • Rational subgrouping
      • Sample Size
      • Other uses for SPC
  • 2:30 PM -2:40 PM Break
  • 2:40 PM -4:30 PM
    • Statistical Process Control (continued)
    • Confidence/Reliability Calculations
      • Regulatory requirements for Reliability, in relation to Risk Management
      • Definition of Confidence
      • Attribute data
      • Variables data, using K-tables
        • Affect of non-Normality
        • Transformation to Normality
        • How to improve accuracy when specification is 2-sided
        • Tolerance Limits
    • Variables data, using Process Capability Indices
      • 6-sigma
      • Cp, Cpk
      • Pp, Ppk
      • Confidence Limits on Cpk and Ppk
      • % In-Specification vs. values of Cpk or Ppk
      • How to improve accuracy when specification is 2-sided
  • 4:30 PM -4:40 PM break
  • 4:40 PM -6:00 PM
    • Confidence/Reliability Calculations (continued)
    • Process Capability Indices (Cp, Cpk, Pp, Ppk)
    • Q&A
Day Two (8:30 AM – 6:00 PM)
  • 08.30 AM - 08.59 AM – Registration, Meet & Greet
  • 9:00 AM -10:30 AM
    • Reliability Plotting
      • Introduction
      • Transformations
      • Comparison to K-tables
      • Examples
    • Process Validation:
      • Justification for size per validation lot
      • Justification for use of only 3 lots
      • Exam calculations
      • Variables data
      • Attribute data
  • 10:30 AM-10:40 AM break
  • 10:40 AM-12:00 PM
    • Statistical Significance
      • Regulatory requirements
      • Definition of Significance
      • t-Test as an example of a Significance Test
      • Null Hypothesis
      • 1-tailed vs. 2-tailed
      • P-value vs. Significance
      • The problem with using Z-tables
      • Meaning of Significance
      • Testing for Superiority
      • Testing for Non-Inferiority
      • TOST
  • 12:00 PM -1:00 PM Lunch
  • 1:00 PM -2:30 PM
    • Statistical Power
      • Regulatory requirements
      • Explanation of Power, using t-Tests
      • Calculation of Power using software
      • Sample size
      • Affect of non-Normality
      • What level of Power is acceptable?
    • Metrology (statistical analysis of measurement uncertainty)
      • MSA-4
      • Regulatory requirements
      • Accuracy vs. Precision vs. Resolution
      • Calibration
      • Gage Correlation
      • Gage Bias
      • Gage Linearity
      • Gage R&R
      • Guard Banding
      • Uncertainty Budget
      • Dry-lab equivalent to a Gage R&R
  • 2:30 PM -2:40 PM Break
  • 2:40 PM -4:30 PM
    • QC Sampling Plans
      • Regulatory requirements
      • Attribute vs. Variables plans
      • AQL vs. LQL
      • ANSI Z1.4
      • C=0
      • Classic AQL QC Sampling Plans
      • OC curves
      • Consumer Risk
      • AOQL
      • Better alternatives to AQL-based QC specifications
    • Statistically Valid Conclusion Statements
  • 4:30 PM -4:40 PM break
  • 4:40 PM -6:00 PM
    • Summary and recommendations
    • Q&A (including analysis of any data brought by students)

Meet Your Instructor

John N Zorich
John N Zorich,
Statistical Consultant and Trainer, Statistical Consultant

John 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. His experience as an instructor in applied statistics includes having given annual 3-day seminars for many years at Ohlone College (San Jose CA), and previously having given that same course for several years for Silicon Valley ASQ Biomedical. He's given numerous statistical seminars at ASQ meetings and conferences. And he creates and sells validated statistical software programs that have been purchased by more than 110 companies, world-wide.

Location :
Houston, TX
(Venue to be announced shortly)
December 5-6, 2019
Register Online

Register Online

$1,699

Seminar One Registration

December 5-6, 2019, Houston, TX
(For Registrations till November 18, 2019 - $1699)
(For Registrations after November 18, 2019 - $1899)

The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both the days.

The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both the days.
For discounts on multiple registrations, contact customer care at +1-1-888-771-6965.

Register by Wire Transfer

If you wish to pay by wire transfer: Please call us at
Toll Free +1-1-888-771-6965

Download Registration Form

Yes, I want to attend "Applied Practical Statistics, with Emphasis on Verification, Validation, Sample Size, and Risk Management in R&D, Mfg. and QA/QC: 2-Day In-Person Seminar"
Click here to Download Registration Form
If you are paying by check:
Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
2479 East Bayshore Road, Suite 260
Palo Alto, CA 94303
USA

Terms & Conditions to register for the Seminar/Conference/Event

Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @ editor@grcseminars.com

Payment:

Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future GRC Seminars event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event GRC Seminars cancels the seminar, GRC Seminars is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and Documents to carry to the seminar venue:

After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:

By registering and attending GRC Seminars conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by GRC Seminars for marketing, archiving or any other conference related activities. You agree to release GRC Seminars for any kind of claims arising out of copyright or privacy violations.

Media Partners

If you wish to partner with us for this event please contact us: partner@grcseminars.com or call us: +1-888-771-6965.
Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.
Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

Local Attractions of Houston, TX

Bayou Place
TLocated in the heart of Houston's Downtown Theater District, this 130,000 square foot entertainment megaplex is comprised of theaters, bars, lounges, and restaurants. Start the evening off with dinner at the legendary Hard Rock Café or the authentic Italian trattoria, Mingalone. Enjoy box office hits or catch the latest indie flick at the Angelika Film Center followed by drinks and dancing at ROCBAR, Houston's largest rock and roll nightclub.

Galleria Mall
The Galleria Houston, Texas's largest mall, is an upscale shopping mall centrally located just outside the 610 loop in Houston's Uptown District. The retail center is anchored by Macy's, Neiman Marcus, Nordstrom and Saks Fifth Avenue, and occupies such high-end tenants as Tiffany and Co., Dior, Louis Vuitton, and Yves Saint Laurent.

Johnson Space Center
The Lyndon B. Johnson Space Center, home of the NASA astronaut corps, is located in Southeast Houston. The center spans 1,620 acres and consists of 100 facilities. Tourists can experience a simulation of a zero-gravity environment in the Living in Space exhibit or encounter a virtual rocket launch complete with exhaust at the Blast Off Theater.

Houston Zoo
Sheltering over 4,500 animals and 900 species, The Houston Zoo is the 7th most visited zoo in the nation. Spend the day strolling through the facility's beautifully landscaped grounds or enjoy a more hands-on encounter by scheduling a guided tour. Tour experiences range from feeding a lion cub to shadowing a staff veterinarian for an entire day.

Museum Distric
The Houston Museum District refers to the collection of museums, galleries, and cultural centers located within a 1.5 mile radius of Herman Park. The Museum of Fine Arts which also houses the Bayou Bend Collection and Gardens, boasts a collection of over 56,000 pieces.