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Chairman
Dr. Wayne A. Taylor   linkedin
President
Ann Taylor
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1 (847) 367-1032
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5510 Fairmont Rd.
Libertyville, IL 60048
USA
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By entering your e-mail address and clicking the Subscribe button, you will automatically be added to our mailing list.  You will receive an e-mail when new versions of our software or books are available as well as other significant announcements.  (privacy policy).

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What's New?

  

Statistical Procedures for the Medical Device Industry - electronic version Statistical Procedures for the Medical Device Industry New(Added 9/25/17)

Provides statistical procedures designed to ensure that all statistical regulatory requirements for medical devices are met. These regulatory requirements can be found in:

Code of Federal Regulation 21CFR, Part 820 Quality System Regulations

ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes

Available as both a hardcopy and pdf.

This book includes step-by-step instruction for executing 43 statistical procedures including confidence intervals, equivalency studies, regression, ANOVA, designed experiments, capability studies, gauge R&R studies, normality testing, sampling plans, control charts, change-point analysis, tolerance analysis and robust design (complete list).  It also provides all the needed rationales, justifications and references.

 

3 New Technical Briefs in Technical Library(Added 9/25/17)

Normalized IN charts solve the issue of not being an able to normalize Individuals (I) charts.  While similar to the Laney U' and P' charts, they can be used in other situations not involving count data.  and IN charts may be the only 2 types of charts you ever need.

The exception to the statement the  and IN charts may be the only 2 types of charts you ever need, is for nonnormal data.  On common case of this is count data were the counts average 10 or less, such as complaint data.  The U and P charts are commonly used in this case.  However, for counts both have increased rates of false signals, possibly as high at 1 in 11.  Adjusted control limits are provided below fixing this issue.

The above technical briefs support STAT-10, Statistical Techniques for Trending Data, from the book Statistical Procedures for the Medical Device Industry.

 

Guide to Acceptance Sampling - First Edition Available Electronically -  (Added 6/3/11)

The second edition is delayed until the end of the year.  In the interim, electronic copies of the first edition may be purchased.  A second edition is planned for Mid 2012.

32-bit versions of the programs can now be downloaded that run on both 32-bit and 64-bits versions of the Windows operating systems.

 

New FDA Guidance Document - Process Validation of Drug(Added 2/6/11)

Issued January 2011 - Food & Drug Administration (FDA): “Process Validation: General Principles and Practices,” January 2011.  Covered in the course Process Validation Principles.  

 

Process Validation Principles - New Course  -  (Added 2/16/08)

Primarily focused on medical devices, covers the FDA regulations and the Global Harmonization Task Force guidelines.

 

Validation by Experimental Design

Pharmaceutical and Medical Device Validation by Experimental Design - New Book -  (Added 1/3/08)

Dr. Taylor authored the chapter "The Role of Designed Experiments in Developing and Validating Control Plans" in the above book.

 

Distribution Analyzer Version 1.2 Released -  (Added 12/25/07)

Version 1.2 of Distribution Analyzer is now available for downloading.  This is a new package to aid in validation, verification and qualification studies.  It aids in the application of normal tolerance intervals and variables sampling plans by testing for normality, transforming the data if necessary and then calculating the confidence statements.  You can download the software and use it free of charge for 30-days.  Version 1.2 updates the help system to operate under Windows Vista and fixes several bugs causing error messages to occur when clicking the Find Best Distribution button.

 

New Course Validation Sampling Plans(Added 4/5/06)

This course covers determining sample sizes and acceptance criteria for validation and other 1-time studies.  It can be offered at your location.

 

New Course Normality and Transformations(Added 4/5/06)

This course covers how to test for normality and handle nonnormal data including fitting other distributions and transforming data.  It can be offered at your location.

 

Book Optimization & Variation Reduction in Quality(Added 7/16/05)

The book Optimization & Variation Reduction in Quality is back in print, this time as soft cover book.

  


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Last modified: September 08, 2017