Online seminar Masters Program in Applied Statistics, with Emphasis on Risk Management, for R&D, Mfg., and QA/QC

John N Zorich
Jun 18 - Jun 18 , 2020
Starting at

$1999


Jun 18 - Jun 18 , 2020
Buy Now

Course Duration 21 Hours

Each day 6 hours session + 1-hour Break

Mode of delivery: Online

Plianced CEU: 18

 

Chapter #

Topic

Date

Time

Chapter 1

Miscellaneous Statistical Methods: QC Sampling Plans, Metrology, Normality Tests & Transformations, Significance Tests, Statistical Power, Statistical Justification for Using only 3 Lots for Process Validation

Jun 18th, 2020

10.00 Am ET

To

5.00 PM ET

Chapter 2

Masters Program in Statistical Methods Involving Confidence: Confidence Intervals, Confidence/Reliability Calculations, and Statistical Tolerance Limits

Jun 25th, 2020

10.00 Am ET

To

5.00 PM ET

Chapter 3

Masters Program in Detailed Introduction to Statistical Process Control (SPC)

July 15th, 2020

10.00 Am ET

To

5.00 PM ET

 

Day 1 (June 18th, 2020 at 10.00 AM ET)

Chapter 1 - Miscellaneous Statistical Methods: QC Sampling Plans, Metrology, Normality Tests & Transformations, Significance Tests, Statistical Power, Statistical Justification for Using only 3 Lots for Process Validation.

Description:

The methods discussed in this webinar form a set of tools that help to manage "risk" in a company. The risk could be: accepting a "bad" lot from a supplier, passing a lot based on inappropriate measurement equipment, approving a bid process based upon the conclusion that it is "statistically" not different than a predicate product, making conclusions based upon methods that require normally distributed data but the actual data used is non-normal, and being unable to tell an auditor why it is OK that process validation was completed using only 3 lots.

Areas Covered in the Chapter:

·         Basic Vocabulary & Concepts

·         QC Sampling Plans (AQL, C=0)

·         Metrology (statistical analysis of measurement uncertainty)

·         Significance Tests & Statistical Power

·         Normality Tests and Normality Transformations

·         Statistical Justification for Using only 3 Lots for Process Validation

Course Agenda of Chapter 1

·         Introductions

·         QC Sampling Plans (AQL, C=0)

·         Metrology (statistical analysis of measurement uncertainty, including Gage R&R, Linearity, and Gage Correlation)

·         Significance Tests & Statistical Power

·         LUNCH

·         Significance Tests & Statistical Power (Contd)

·         Normality Tests and Normality Transformations

·         Statistical Justification for Using only 3 Lots for Process Validation

·         Q&A and End of Session 1

 

Day 2 (Jun 25th, 2020 at 10.00 AM ET)

Chapter 2 - Miscellaneous Statistical Methods: QC Sampling Plans, Metrology, Normality Tests & Transformations, Significance Tests, Statistical Power, Statistical Justification for Using only 3 Lots for Process Validation.

Description:

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 tests/inspections may occur during design verification/validation or during incoming or final QC. The most informative methods for analyzing the data that results from such activities are the calculation of the product's or lot's true values for either the...

·         interval in which the products true mean is expected to be found (i.e., the "confidence interval")

·         "%reliability" (= % of the population that is expected to be in-specification)

·         Interval in which at least a specified % of the population is expected to be found.

Such "confidence" methods produce information that is highly valuable, as opposed to lower value conclusions that (1) a given product or lot "passed" (as is the case when "AQL Attribute Sampling Plans" are used) or that (2) the sample exhibited XX% in-specification, without any corresponding confidence statement (as is the case with classic Process Capability calculations or with AQL Variables Sampling Plans).

Areas Covered in the Sessions:

  1. Basic Vocabulary & Concepts
  2. Confidence Intervals (for measurement data, and for percentages)
  3. Confidence / Reliability Calculations (for measurement data, and for percentages, for normal and non-normal data)
  4. Statistical Tolerance Limits (normal and non-normal)

Course Agenda of Chapter 2

·         Basic Vocabulary & Concepts

·         Confidence Intervals

·         Confidence / Reliability Calculations (normally distributed data, using K-tables)

·         Lunch

·         Confidence / Reliability Calculations (for transformed data, using K-tables)

·         Confidence / Reliability Calculations (for data that cannot be transformed to normality, using "Reliability Plotting")

·         Statistical Tolerance Limits ("normal" and "non-normal")

·         Q&A and End of Session 2

Day 3 (Jul 15th, 2020 at 10.00 AM ET)

Chapter 3 - Detailed Introduction to Statistical Process Control (SPC)

Description:

All companies want to improve the quality of their products. Attempts to improve product quality need to be structured in such a way that they have a reasonable chance of success and the cost/benefit ratio is appropriate. The most successful method available for such endeavors is called SPC (statistical process control).  SPC can also be used to meet ISO requirements for "continual improvement" as well as FDA requirements to "control and monitor production processes". SPC can even be used to monitor complaint rates, to determine if there has been a "significant" increase in complaints, which would, therefore, trigger an MDD "vigilance report" and/or an FDA MDR submission.

Areas Covered in the Sessions:

·         Basic Vocabulary & Concepts

·         Types of Control Charts

·         Calculation of Control Chart Limits

·         Detecting "Out of Control"

·         Sample Size & Sampling Considerations

·         Capability Indices: Cp, Pp, Cpk, Ppk

·         How to Handle "Non-normal" data

·         How to Initiate and Manage a Successful SPC Program

 

Course Agenda of Chapter 3

·         Basic Vocabulary & Concepts

·         Types of Control Charts

·         Calculation of Control Chart Limits

·         Lunch

·         Calculation of Control Chart Limits (continued)

·         Sample Size & Sampling Considerations

·         Capability Indices

·         Non-Normal Data

·         How to Initiate and Manage a Successful SPC Program

·         Q&A and End of Session 3

 

Target Audience:

·         QA/QC Supervisor

·         Process Engineer

·         Manufacturing Engineer

·         QC/QC Technician

·         Manufacturing Technician

·         R&D Engineer

Seminar (Price/Register)
Jun 18 - Jun 18 , 2020

Single Attendee


Group of 3 to 5 +1 Thumb Drive or 5 online Recorded version


Group of 6 to 10 +1 Thumb Drive or 10 online Recorded version

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

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Speaker: John N Zorich , Statistical Consultant and Trainer, Statistical Consult

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.


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