APPLIED PRACTICAL STATISTICS, With emphasis On Verification, Validation, Sample Size, & Risk Management, In R+D, Mfg., & QA/QC

These multi-hour seminars are given via webinar (WebEx).
shorter Webinars are also available (click on “webinars” link, above).

SEMINAR IN APPLIED STATISTICS — Three 2-day seminars (3.5 Hrs / day)

I’ve given this seminar annually since 2005, at the Biotechnology Center of Ohlone Community College (Silicon Valley). Starting in 2020, it’s been given via webinar instead of in-person. The first 2-day seminar (“BASIC”) is mostly remedial training for those who have never taken a statistics course (or who have taken it so long ago that they want a refresher in the basics). The second (“INTERMEDIATE”) and third (“ADVANCED”) 2-day seminars provide training in how to use specific statistical techniques that are commonly used in R&D, Manufacturing, and QA/QC, most especially in the medical device industry. The full title of the seminar is…

APPLIED   STATISTICS, With EMPHASIS On RISK MANAGEMENT,   For  QA/QC, MFG.,  And  R&D

Each of these 3 seminars are 7 hours of class-time (3.5 hours per day over 2 consecutive days) starting at 8:30am California time, and ending at Noon.
Attendees may sign-up for any combination of Basic (July 10+11), Intermediate (July 17+18), or Advanced (July 24+25) seminars.   
Only one logon allowed per registration, altho multiple persons are allowed to listen-in on that one logon.
For each 2-day seminar attended, Ohlone will send an “attendance certificate”
only to the registered person, as long as that person is actually logged on during the several times each day that Ohlone administrative personnel will be secretly checking attendance.

Registration and payment is via Ohlone College's website at the following webpage (same for all 3 days):

https://ohlone.augusoft.net/index.cfm?method=ClassListing.ClassListingDisplay&int_category_id=21&int_sub_category_id=310&int_catalog_id=

Ohlone has set the price for 2024 at $135 per day per registration (i.e. per logon).

A LIMITED NUMBER OF PARTIAL SCHOLARSHIPS ARE AVAILABLE FOR THE UNEMPLOYED. To obtain a scholarship, do NOT contact the host college, but rather contact the instructor by email at… JOHNZORICH@YAHOO.COM. The reduced price will be effected via a refund by hard-copy check of $100 per course-day actually attended.

The seminar  is targeted at the medical device industry, but has been found very useful by those in the pharmaceutical and other biotech industries, as well as by any industry that designs and/or makes products packaged in single units (as opposed to bulk solutions or bulk products like rolls of carpet).  Prior to each seminar, students are given a set of spreadsheets designed to help teach the topics and to be used back at work to enforce and practice what's been learned.                                  

BASIC topics, part 1: July 10, Part 2: July 11, 3.5 hours per day

  • Regulatory Requirements

  • Population vs. Sample

  • Parameter vs. Statistic

  • Probability

  • Law of Large Numbers

  • Distributions (in general)

  • Binomial Distribution

  • Normal Distribution

  • Central Limit Theorem

  • Standard Deviation and Standard Error

  • Linear Regression and Correlation Coefficients

  • Open-book quiz & then discuss the answers.

INTERMEDIATE topics, part 1: July 17, Part 2: July 18, 3.5 hours per day

  • Regulatory Requirements

  • Confidence Intervals

  • Significance Tests

  • Null Hypothesis

  • t-Tests   

  • P-values

  • Power calculations (t-Tests will be used as an example)

  • Confidence and Reliability (=% in-specification) Calculations (a.k.a., process capability calculations)

    • Attribute ( pass / fail ) data

    • Variables (measurement) data

    • Normal vs. Non-normal data

    • K-tables (for Normally-distributed data)

  • Normality Tests, and How to Transform Non-Normal data into Normality

  • Statistical Justification for Sample Sizes and the use of only 3 Validation Lots

  • Open-book quiz & then discuss the answers.

ADVANCED topics, part 1: July 24, Part 2: July 25, 3.5 hours per day

  • Regulatory Requirements

  • Statistical Tolerance Limits

  • Reliability Plotting: confidence and reliability calculations (=% in-specification, a.k.a. process capability) for...

    • Data that cannot be transformed to Normality

    • Data with many replicate values

    • Data from incomplete studies (i.e., time or equipment censored)

    • Data comprising a mixture of distributions (bi-modal, tri-modal,...)

  • Metrology: Statistical Analysis of Measurement Variation (and how to use such information to set rational QC specifications)

  • QC Sampling Plans (and how to determine if they are statistically valid, and what are better alternatives to using AQL plans)

  • Statistical Process Control (SPC) Control charts (variables data, and count data)

  • Process Capability Indices

  • Open-book quiz & then discuss the answers.